New drugs (FDA record)

Name: WW9 Atlas: New drugs (FDA record)
Creator: WorldW9r

Every new-molecule drug the FDA approved, by date, at the company that made it. 981 points on the WW9 Atlas, oldest first, each with its source.

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Reblozyl (luspatercept-aamt)2019 · FDA new drug approval · Celgene headquarters, SummitNew drug approved by the FDA on 2019-11-08. Active ingredient: luspatercept-aamt. Sponsor: Celgene Corp. Application BLA761136.FDA Drugs@FDA, application BLA761136 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761136)
Reyvow (lasmiditan succinate)2019 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2019-10-11. Active ingredient: lasmiditan succinate. Sponsor: Eli Lilly And Co. Application NDA211280.FDA Drugs@FDA, application NDA211280 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211280)
Rinvoq (upadacitinib)2019 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2019-08-16. Active ingredient: upadacitinib. Sponsor: Abbvie. Application NDA211675.FDA Drugs@FDA, application NDA211675 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211675)
Rozlytrek (entrectinib)2019 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2019-08-15. Active ingredient: entrectinib. Sponsor: Genentech Inc. Application NDA212725.FDA Drugs@FDA, application NDA212725 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212725)
Skyrizi (risankizumab-rzaa)2019 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2019-04-23. Active ingredient: risankizumab-rzaa. Sponsor: Abbvie Inc. Application BLA761105.FDA Drugs@FDA, application BLA761105 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761105)
Turalio (pexidartinib hydrochloride)2019 · FDA new drug approval · Daiichi Sankyo headquarters, ChūōNew drug approved by the FDA on 2019-08-02. Active ingredient: pexidartinib hydrochloride. Sponsor: Daiichi Sankyo Inc. Application NDA211810.FDA Drugs@FDA, application NDA211810 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211810)
Ubrelvy (ubrogepant)2019 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2019-12-23. Active ingredient: ubrogepant. Sponsor: Abbvie. Application NDA211765.FDA Drugs@FDA, application NDA211765 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211765)
Xcopri (cenobamate)2019 · FDA new drug approval · SK Life Science (United States) headquarters, Fair LawnNew drug approved by the FDA on 2019-11-21. Active ingredient: cenobamate. Sponsor: Sk Life. Application NDA212839.FDA Drugs@FDA, application NDA212839 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212839)
Artesunate (artesunate)2020 · FDA new drug approval · AMIVASAN headquarters, PragueNew drug approved by the FDA on 2020-05-26. Active ingredient: artesunate. Sponsor: Amivas. Application NDA213036.FDA Drugs@FDA, application NDA213036 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213036)
Ayvakit (avapritinib)2020 · FDA new drug approval · Blueprint Medicines (United States) headquarters, CambridgeNew drug approved by the FDA on 2020-01-09. Active ingredient: avapritinib. Sponsor: Blueprint Medicines. Application NDA212608.FDA Drugs@FDA, application NDA212608 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212608)
Cerianna (fluoroestradiol f-18)2020 · FDA new drug approval · GE HealthCare headquarters, Little ChalfontNew drug approved by the FDA on 2020-05-20. Active ingredient: fluoroestradiol f-18. Sponsor: Ge Healthcare. Application NDA212155.FDA Drugs@FDA, application NDA212155 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212155)
Dojolvi (triheptanoin)2020 · FDA new drug approval · Ultragenyx Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2020-06-30. Active ingredient: triheptanoin. Sponsor: Ultragenyx Pharm Inc. Application NDA213687.FDA Drugs@FDA, application NDA213687 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213687)
Ebanga (ansuvimab-zykl)2020 · FDA new drug approval · Ridgeback Biotherapeutics headquarters, MiamiNew drug approved by the FDA on 2020-12-21. Active ingredient: ansuvimab-zykl. Sponsor: Ridgeback Biotherapeutics. Application BLA761172.FDA Drugs@FDA, application BLA761172 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761172)
Enspryng (satralizumab)2020 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2020-08-14. Active ingredient: satralizumab. Sponsor: Genentech. Application BLA761149.FDA Drugs@FDA, application BLA761149 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761149)
Evrysdi (risdiplam)2020 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2020-08-07. Active ingredient: risdiplam. Sponsor: Genentech Inc. Application NDA213535.FDA Drugs@FDA, application NDA213535 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213535)
Inmazeb (atoltivimab, maftivimab, odesivimab)2020 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2020-10-14. Active ingredient: atoltivimab, maftivimab, odesivimab. Sponsor: Regeneron Pharmaceuticals. Application BLA761169.FDA Drugs@FDA, application BLA761169 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761169)
Klisyri (tirbanibulin)2020 · FDA new drug approval · Almirall headquarters, BarcelonaNew drug approved by the FDA on 2020-12-14. Active ingredient: tirbanibulin. Sponsor: Almirall. Application NDA213189.FDA Drugs@FDA, application NDA213189 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213189)
Koselugo (selumetinib sulfate)2020 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2020-04-10. Active ingredient: selumetinib sulfate. Sponsor: Astrazeneca. Application NDA213756.FDA Drugs@FDA, application NDA213756 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213756)
Lampit (nifurtimox)2020 · FDA new drug approval · Bayer HealthCare headquarters, LeverkusenNew drug approved by the FDA on 2020-08-06. Active ingredient: nifurtimox. Sponsor: Bayer Healthcare. Application NDA213464.FDA Drugs@FDA, application NDA213464 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213464)
Monjuvi (tafasitamab-cxix)2020 · FDA new drug approval · Morphosys headquarters, MunichNew drug approved by the FDA on 2020-07-31. Active ingredient: tafasitamab-cxix. Sponsor: Morphosys Us Inc. Application BLA761163.FDA Drugs@FDA, application BLA761163 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761163)
Nurtec Odt (rimegepant sulfate)2020 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2020-02-27. Active ingredient: rimegepant sulfate. Sponsor: Pfizer. Application NDA212728.FDA Drugs@FDA, application NDA212728 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212728)
Ongentys (opicapone)2020 · FDA new drug approval · Amneal Pharmaceuticals, Inc. headquarters, HaywardNew drug approved by the FDA on 2020-04-24. Active ingredient: opicapone. Sponsor: Amneal. Application NDA212489.FDA Drugs@FDA, application NDA212489 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212489)
Orladeyo (berotralstat dihydrochloride)2020 · FDA new drug approval · BioCryst Pharmaceuticals headquarters, DurhamNew drug approved by the FDA on 2020-12-03. Active ingredient: berotralstat dihydrochloride. Sponsor: Biocryst. Application NDA214094.FDA Drugs@FDA, application NDA214094 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214094)
Pemazyre (pemigatinib)2020 · FDA new drug approval · Incyte headquarters, WilmingtonNew drug approved by the FDA on 2020-04-17. Active ingredient: pemigatinib. Sponsor: Incyte Corp. Application NDA213736.FDA Drugs@FDA, application NDA213736 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213736)
Retevmo (selpercatinib)2020 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2020-05-08. Active ingredient: selpercatinib. Sponsor: Eli Lilly And Co. Application NDA213246.FDA Drugs@FDA, application NDA213246 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213246)
Sarclisa (isatuximab-irfc)2020 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2020-03-02. Active ingredient: isatuximab-irfc. Sponsor: Sanofi Aventis Us. Application BLA761113.FDA Drugs@FDA, application BLA761113 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761113)
Sogroya (somapacitan-beco)2020 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2020-08-28. Active ingredient: somapacitan-beco. Sponsor: Novo Nordisk Inc. Application BLA761156.FDA Drugs@FDA, application BLA761156 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761156)
Tabrecta (capmatinib hydrochloride)2020 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2020-05-06. Active ingredient: capmatinib hydrochloride. Sponsor: Novartis Pharm. Application NDA213591.FDA Drugs@FDA, application NDA213591 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213591)
Tazverik (tazemetostat hydrobromide)2020 · FDA new drug approval · Epizyme (United States) headquarters, CambridgeNew drug approved by the FDA on 2020-01-23. Active ingredient: tazemetostat hydrobromide. Sponsor: Epizyme Inc. Application NDA211723.FDA Drugs@FDA, application NDA211723 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211723)
Trodelvy (sacituzumab govitecan-hziy)2020 · FDA new drug approval · Immunomedics (United States) headquarters, Morris PlainsNew drug approved by the FDA on 2020-04-22. Active ingredient: sacituzumab govitecan-hziy. Sponsor: Immunomedics Inc. Application BLA761115.FDA Drugs@FDA, application BLA761115 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761115)
Tukysa (tucatinib)2020 · FDA new drug approval · Seagen headquarters, BothellNew drug approved by the FDA on 2020-04-17. Active ingredient: tucatinib. Sponsor: Seagen. Application NDA213411.FDA Drugs@FDA, application NDA213411 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213411)
Veklury (remdesivir)2020 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2020-10-22. Active ingredient: remdesivir. Sponsor: Gilead Sciences Inc. Application NDA214787.FDA Drugs@FDA, application NDA214787 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214787)
Viltepso (viltolarsen)2020 · FDA new drug approval · Nippon Shinyaku headquarters, Kyoto PrefectureNew drug approved by the FDA on 2020-08-12. Active ingredient: viltolarsen. Sponsor: Nippon Shinyaku. Application NDA212154.FDA Drugs@FDA, application NDA212154 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212154)
Vyepti (eptinezumab-jjmr)2020 · FDA new drug approval · Lundbeck Seattle Biopharmaceuticals headquarters, BothellNew drug approved by the FDA on 2020-02-21. Active ingredient: eptinezumab-jjmr. Sponsor: Lundbeck Seattle Biopharmaceuticals, Inc.. Application BLA761119.FDA Drugs@FDA, application BLA761119 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761119)
Winlevi (clascoterone)2020 · FDA new drug approval · Sun Pharmaceutical headquarters, MumbaiNew drug approved by the FDA on 2020-08-26. Active ingredient: clascoterone. Sponsor: Sun Pharm. Application NDA213433.FDA Drugs@FDA, application NDA213433 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213433)
Aduhelm (aducanumab-avwa)2021 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2021-06-07. Active ingredient: aducanumab-avwa. Sponsor: Biogen Inc. Application BLA761178.FDA Drugs@FDA, application BLA761178 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761178)
Brexafemme (ibrexafungerp citrate)2021 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2021-06-01. Active ingredient: ibrexafungerp citrate. Sponsor: Glaxosmithkline. Application NDA214900.FDA Drugs@FDA, application NDA214900 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214900)
Cosela (trilaciclib dihydrochloride)2021 · FDA new drug approval · Pharmacosmos headquarters, HolbækNew drug approved by the FDA on 2021-02-12. Active ingredient: trilaciclib dihydrochloride. Sponsor: Pharmacosmos. Application NDA214200.FDA Drugs@FDA, application NDA214200 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214200)
Evkeeza (evinacumab-dgnb)2021 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2021-02-11. Active ingredient: evinacumab-dgnb. Sponsor: Regeneron Pharmaceuticals. Application BLA761181.FDA Drugs@FDA, application BLA761181 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761181)
Fexinidazole (fexinidazole)2021 · FDA new drug approval · Sanofi headquarters, ParisNew drug approved by the FDA on 2021-07-16. Active ingredient: fexinidazole. Sponsor: Sanofi. Application NDA214429.FDA Drugs@FDA, application NDA214429 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214429)
Jemperli (dostarlimab-gxly)2021 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2021-04-22. Active ingredient: dostarlimab-gxly. Sponsor: Glaxosmithkline. Application BLA761174.FDA Drugs@FDA, application BLA761174 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761174)
Leqvio (inclisiran sodium)2021 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2021-12-22. Active ingredient: inclisiran sodium. Sponsor: Novartis. Application NDA214012.FDA Drugs@FDA, application NDA214012 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214012)
Lumakras (sotorasib)2021 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2021-05-28. Active ingredient: sotorasib. Sponsor: Amgen Inc. Application NDA214665.FDA Drugs@FDA, application NDA214665 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214665)
Nexviazyme (avalglucosidase alfa-ngpt)2021 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2021-08-06. Active ingredient: avalglucosidase alfa-ngpt. Sponsor: Genzyme Corp. Application BLA761194.FDA Drugs@FDA, application BLA761194 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761194)
Qulipta (atogepant)2021 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2021-09-28. Active ingredient: atogepant. Sponsor: Abbvie. Application NDA215206.FDA Drugs@FDA, application NDA215206 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215206)
Rybrevant (amivantamab-vmjw)2021 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2021-05-21. Active ingredient: amivantamab-vmjw. Sponsor: Janssen Biotech. Application BLA761210.FDA Drugs@FDA, application BLA761210 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761210)
Saphnelo (anifrolumab-fnia)2021 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2021-07-30. Active ingredient: anifrolumab-fnia. Sponsor: Astrazeneca Ab. Application BLA761123.FDA Drugs@FDA, application BLA761123 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761123)
Scemblix (asciminib hydrochloride)2021 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2021-10-29. Active ingredient: asciminib hydrochloride. Sponsor: Novartis. Application NDA215358.FDA Drugs@FDA, application NDA215358 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215358)
Tavneos (avacopan)2021 · FDA new drug approval · ChemoCentryx (United States) headquarters, Mountain ViewNew drug approved by the FDA on 2021-10-07. Active ingredient: avacopan. Sponsor: Chemocentryx. Application NDA214487.FDA Drugs@FDA, application NDA214487 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214487)
Tepmetko (tepotinib hydrochloride)2021 · FDA new drug approval · Merck KGaA headquarters, DarmstadtNew drug approved by the FDA on 2021-02-03. Active ingredient: tepotinib hydrochloride. Sponsor: Emd Serono Inc. Application NDA214096.FDA Drugs@FDA, application NDA214096 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214096)
Tezspire (tezepelumab-ekko)2021 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2021-12-17. Active ingredient: tezepelumab-ekko. Sponsor: Astrazeneca Ab. Application BLA761224.FDA Drugs@FDA, application BLA761224 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761224)
Tivdak (tisotumab vedotin-tftv)2021 · FDA new drug approval · Seagen headquarters, BothellNew drug approved by the FDA on 2021-09-20. Active ingredient: tisotumab vedotin-tftv. Sponsor: Seagen. Application BLA761208.FDA Drugs@FDA, application BLA761208 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761208)
Verquvo (vericiguat)2021 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2021-01-19. Active ingredient: vericiguat. Sponsor: Msd. Application NDA214377.FDA Drugs@FDA, application NDA214377 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214377)
Voxzogo (vosoritide)2021 · FDA new drug approval · BioMarin Pharmaceutical headquarters, NovatoNew drug approved by the FDA on 2021-11-19. Active ingredient: vosoritide. Sponsor: Biomarin Pharm. Application NDA214938.FDA Drugs@FDA, application NDA214938 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214938)
Welireg (belzutifan)2021 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2021-08-13. Active ingredient: belzutifan. Sponsor: Merck Sharp Dohme. Application NDA215383.FDA Drugs@FDA, application NDA215383 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215383)
Zynlonta (loncastuximab tesirine-lpyl)2021 · FDA new drug approval · ADC Therapeutics headquarters, LausanneNew drug approved by the FDA on 2021-04-23. Active ingredient: loncastuximab tesirine-lpyl. Sponsor: Adc Therapeutics Sa. Application BLA761196.FDA Drugs@FDA, application BLA761196 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761196)
Briumvi (ublituximab-xiiy)2022 · FDA new drug approval · TG Therapeutics headquarters, New York CityNew drug approved by the FDA on 2022-12-28. Active ingredient: ublituximab-xiiy. Sponsor: Tg Therapeutics, Inc. Application BLA761238.FDA Drugs@FDA, application BLA761238 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761238)
Cibinqo (abrocitinib)2022 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2022-01-14. Active ingredient: abrocitinib. Sponsor: Pfizer. Application NDA213871.FDA Drugs@FDA, application NDA213871 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213871)
Daxxify (daxibotulinumtoxina-lanm)2022 · FDA new drug approval · Revance Therapeutics, Inc. headquarters, NewarkNew drug approved by the FDA on 2022-09-07. Active ingredient: daxibotulinumtoxina-lanm. Sponsor: Revance Therapeutics, Inc.. Application BLA761127.FDA Drugs@FDA, application BLA761127 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761127)
Elahere (mirvetuximab soravtansine-gynx)2022 · FDA new drug approval · ImmunoGen Inc. headquarters, WalthamNew drug approved by the FDA on 2022-11-14. Active ingredient: mirvetuximab soravtansine-gynx. Sponsor: Immunogen Inc. Application BLA761310.FDA Drugs@FDA, application BLA761310 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761310)
Imjudo (tremelimumab-actl)2022 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2022-10-21. Active ingredient: tremelimumab-actl. Sponsor: Astrazeneca Ab. Application BLA761289.FDA Drugs@FDA, application BLA761289 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761289)
Kimmtrak (tebentafusp-tebn)2022 · FDA new drug approval · Immunocore headquarters, Abingdon-on-ThamesNew drug approved by the FDA on 2022-01-25. Active ingredient: tebentafusp-tebn. Sponsor: Immunocore Ltd. Application BLA761228.FDA Drugs@FDA, application BLA761228 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761228)
Lunsumio Velo (mosunetuzumab-axgb)2022 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2022-12-22. Active ingredient: mosunetuzumab-axgb. Sponsor: Genentech Inc. Application BLA761263.FDA Drugs@FDA, application BLA761263 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761263)
Lytgobi (futibatinib)2022 · FDA new drug approval · Taiho Oncology (United States) headquarters, PrincetonNew drug approved by the FDA on 2022-09-30. Active ingredient: futibatinib. Sponsor: Taiho Oncology. Application NDA214801.FDA Drugs@FDA, application NDA214801 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214801)
Mounjaro (tirzepatide)2022 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2022-05-13. Active ingredient: tirzepatide. Sponsor: Eli Lilly And Co. Application NDA215866.FDA Drugs@FDA, application NDA215866 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866)
Nexobrid (anacaulase-bcdb)2022 · FDA new drug approval · MediWound (Israel) headquarters, Yavne'elNew drug approved by the FDA on 2022-12-28. Active ingredient: anacaulase-bcdb. Sponsor: Mediwound, Ltd. Application BLA761192.FDA Drugs@FDA, application BLA761192 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761192)
Opdualag (nivolumab, relatlimab-rmbw)2022 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2022-03-18. Active ingredient: nivolumab, relatlimab-rmbw. Sponsor: Bristol Myers Squibb. Application BLA761234.FDA Drugs@FDA, application BLA761234 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761234)
Pluvicto (lutetium lu-177 vipivotide tetraxetan)2022 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2022-03-23. Active ingredient: lutetium lu-177 vipivotide tetraxetan. Sponsor: Novartis. Application NDA215833.FDA Drugs@FDA, application NDA215833 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215833)
Relyvrio (sodium phenylbutyrate, taurursodiol)2022 · FDA new drug approval · Amylyx Pharmaceuticals headquarters, CambridgeNew drug approved by the FDA on 2022-09-29. Active ingredient: sodium phenylbutyrate, taurursodiol. Sponsor: Amylyx. Application NDA216660.FDA Drugs@FDA, application NDA216660 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216660)
Spevigo (spesolimab-sbzo)2022 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2022-09-01. Active ingredient: spesolimab-sbzo. Sponsor: Boehringer Ingelheim Pharmaceuticals Inc. Application BLA761244.FDA Drugs@FDA, application BLA761244 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761244)
Sunlenca (lenacapavir sodium)2022 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2022-12-22. Active ingredient: lenacapavir sodium. Sponsor: Gilead Sciences Inc. Application NDA215973.FDA Drugs@FDA, application NDA215973 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215973)
Sunlenca (lenacapavir sodium)2022 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2022-12-22. Active ingredient: lenacapavir sodium. Sponsor: Gilead Sciences Inc. Application NDA215974.FDA Drugs@FDA, application NDA215974 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215974)
Tecvayli (teclistamab-cqyv)2022 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2022-10-25. Active ingredient: teclistamab-cqyv. Sponsor: Janssen Biotech. Application BLA761291.FDA Drugs@FDA, application BLA761291 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761291)
Vabysmo (faricimab-svoa)2022 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2022-01-28. Active ingredient: faricimab-svoa. Sponsor: Genentech Inc. Application BLA761235.FDA Drugs@FDA, application BLA761235 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761235)
Vonjo (pacritinib citrate)2022 · FDA new drug approval · Swedish Orphan Biovitrum headquarters, StockholmNew drug approved by the FDA on 2022-02-28. Active ingredient: pacritinib citrate. Sponsor: Sobi. Application NDA208712.FDA Drugs@FDA, application NDA208712 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208712)
Vtama (tapinarof)2022 · FDA new drug approval · Organon & Co. headquarters, OssNew drug approved by the FDA on 2022-05-23. Active ingredient: tapinarof. Sponsor: Organon Llc. Application NDA215272.FDA Drugs@FDA, application NDA215272 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215272)
Xenpozyme (olipudase alfa-rpcp)2022 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2022-08-31. Active ingredient: olipudase alfa-rpcp. Sponsor: Genzyme Corp. Application BLA761261.FDA Drugs@FDA, application BLA761261 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761261)
Beyfortus (nirsevimab-alip)2023 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2023-07-17. Active ingredient: nirsevimab-alip. Sponsor: Astrazeneca Ab. Application BLA761328.FDA Drugs@FDA, application BLA761328 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761328)
Columvi (glofitamab-gxbm)2023 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2023-06-15. Active ingredient: glofitamab-gxbm. Sponsor: Genentech Inc. Application BLA761309.FDA Drugs@FDA, application BLA761309 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761309)
Elfabrio (pegunigalsidase alfa-iwxj)2023 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2023-05-09. Active ingredient: pegunigalsidase alfa-iwxj. Sponsor: Chiesi Farmaceutici Spa. Application BLA761161.FDA Drugs@FDA, application BLA761161 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761161)
Elrexfio (elranatamab)2023 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2023-08-14. Active ingredient: elranatamab. Sponsor: Pfizer Inc. Application BLA761345.FDA Drugs@FDA, application BLA761345 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761345)
Epkinly (epcoritamab-bysp)2023 · FDA new drug approval · Genmab headquarters, CopenhagenNew drug approved by the FDA on 2023-05-19. Active ingredient: epcoritamab-bysp. Sponsor: Genmab Us, Inc.. Application BLA761324.FDA Drugs@FDA, application BLA761324 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761324)
Fabhalta (iptacopan hydrochloride)2023 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2023-12-05. Active ingredient: iptacopan hydrochloride. Sponsor: Novartis. Application NDA218276.FDA Drugs@FDA, application NDA218276 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218276)
Filsuvez (birch triterpenes)2023 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2023-12-18. Active ingredient: birch triterpenes. Sponsor: Chiesi. Application NDA215064.FDA Drugs@FDA, application NDA215064 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215064)
Izervay (avacincaptad pegol sodium)2023 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2023-08-04. Active ingredient: avacincaptad pegol sodium. Sponsor: Astellas. Application NDA217225.FDA Drugs@FDA, application NDA217225 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217225)
Jesduvroq (daprodustat)2023 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2023-02-01. Active ingredient: daprodustat. Sponsor: Glaxosmithkline. Application NDA216951.FDA Drugs@FDA, application NDA216951 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216951)
Lamzede (velmanase alfa-tycv)2023 · FDA new drug approval · Chiesi Farmaceutici S.p.A. headquarters, ParmaNew drug approved by the FDA on 2023-02-16. Active ingredient: velmanase alfa-tycv. Sponsor: Chiesi Farmaceutici Spa. Application BLA761278.FDA Drugs@FDA, application BLA761278 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761278)
Leqembi (lecanemab-irmb)2023 · FDA new drug approval · Eisai headquarters, TokyoNew drug approved by the FDA on 2023-01-06. Active ingredient: lecanemab-irmb. Sponsor: Eisai Inc. Application BLA761269.FDA Drugs@FDA, application BLA761269 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761269)
Litfulo (ritlecitinib tosylate)2023 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2023-06-23. Active ingredient: ritlecitinib tosylate. Sponsor: Pfizer. Application NDA215830.FDA Drugs@FDA, application NDA215830 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215830)
Loqtorzi (toripalimab-tpzi)2023 · FDA new drug approval · Coherus BioSciences (United States) headquarters, Redwood CityNew drug approved by the FDA on 2023-10-27. Active ingredient: toripalimab-tpzi. Sponsor: Coherus Biosciences Inc. Application BLA761240.FDA Drugs@FDA, application BLA761240 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761240)
Miebo (perfluorohexyloctane)2023 · FDA new drug approval · Bausch & Lomb headquarters, RochesterNew drug approved by the FDA on 2023-05-18. Active ingredient: perfluorohexyloctane. Sponsor: Bausch And Lomb Inc. Application NDA216675.FDA Drugs@FDA, application NDA216675 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216675)
Ngenla (somatrogon-ghla)2023 · FDA new drug approval · Pfizer Ireland Pharmaceuticals headquarters, CorkNew drug approved by the FDA on 2023-06-27. Active ingredient: somatrogon-ghla. Sponsor: Pfizer Ireland Pharmaceuticals. Application BLA761184.FDA Drugs@FDA, application BLA761184 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761184)
Ojjaara (momelotinib dihydrochloride)2023 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2023-09-15. Active ingredient: momelotinib dihydrochloride. Sponsor: Glaxosmithkline. Application NDA216873.FDA Drugs@FDA, application NDA216873 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216873)
Omvoh (mirikizumab-mrkz)2023 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2023-10-26. Active ingredient: mirikizumab-mrkz. Sponsor: Eli Lilly And Co. Application BLA761279.FDA Drugs@FDA, application BLA761279 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761279)
Paxlovid (Copackaged) (nirmatrelvir, ritonavir)2023 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2023-05-25. Active ingredient: nirmatrelvir, ritonavir. Sponsor: Pfizer. Application NDA217188.FDA Drugs@FDA, application NDA217188 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217188)
Pombiliti (cipaglucosidase alfa-atga)2023 · FDA new drug approval · Amicus Therapeutics headquarters, CranburyNew drug approved by the FDA on 2023-09-28. Active ingredient: cipaglucosidase alfa-atga. Sponsor: Amicus Therap Us. Application BLA761204.FDA Drugs@FDA, application BLA761204 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761204)
Rezzayo (rezafungin acetate)2023 · FDA new drug approval · Mundipharma headquarters, Limburg an der LahnNew drug approved by the FDA on 2023-03-22. Active ingredient: rezafungin acetate. Sponsor: Mundipharma. Application NDA217417.FDA Drugs@FDA, application NDA217417 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217417)
Rivfloza (nedosiran sodium)2023 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2023-09-29. Active ingredient: nedosiran sodium. Sponsor: Novo. Application NDA215842.FDA Drugs@FDA, application NDA215842 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215842)
Rystiggo (rozanolixizumab-noli)2023 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 2023-06-26. Active ingredient: rozanolixizumab-noli. Sponsor: Ucb Inc. Application BLA761286.FDA Drugs@FDA, application BLA761286 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761286)
Skyclarys (omaveloxolone)2023 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2023-02-28. Active ingredient: omaveloxolone. Sponsor: Biogen Us. Application NDA216718.FDA Drugs@FDA, application NDA216718 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216718)
Talvey (talquetamab-tgvs)2023 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2023-08-09. Active ingredient: talquetamab-tgvs. Sponsor: Janssen Biotech. Application BLA761342.FDA Drugs@FDA, application BLA761342 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761342)
Truqap (capivasertib)2023 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2023-11-16. Active ingredient: capivasertib. Sponsor: Astrazeneca. Application NDA218197.FDA Drugs@FDA, application NDA218197 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218197)
Vanflyta (quizartinib dihydrochloride)2023 · FDA new drug approval · Daiichi Sankyo headquarters, ChūōNew drug approved by the FDA on 2023-07-20. Active ingredient: quizartinib dihydrochloride. Sponsor: Daiichi Sankyo Inc. Application NDA216993.FDA Drugs@FDA, application NDA216993 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216993)
Velsipity (etrasimod arginine)2023 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2023-10-12. Active ingredient: etrasimod arginine. Sponsor: Pfizer. Application NDA216956.FDA Drugs@FDA, application NDA216956 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216956)
Veopoz (pozelimab-bbfg)2023 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2023-08-18. Active ingredient: pozelimab-bbfg. Sponsor: Regeneron Pharmaceuticals. Application BLA761339.FDA Drugs@FDA, application BLA761339 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761339)
Veozah (fezolinetant)2023 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2023-05-12. Active ingredient: fezolinetant. Sponsor: Astellas. Application NDA216578.FDA Drugs@FDA, application NDA216578 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216578)
Wainua (Autoinjector) (eplontersen sodium)2023 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2023-12-21. Active ingredient: eplontersen sodium. Sponsor: Astrazeneca Ab. Application NDA217388.FDA Drugs@FDA, application NDA217388 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217388)
Zavzpret (zavegepant hydrochloride)2023 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2023-03-09. Active ingredient: zavegepant hydrochloride. Sponsor: Pfizer. Application NDA216386.FDA Drugs@FDA, application NDA216386 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216386)
Zilbrysq (zilucoplan sodium)2023 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 2023-10-17. Active ingredient: zilucoplan sodium. Sponsor: Ucb Inc. Application NDA216834.FDA Drugs@FDA, application NDA216834 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216834)
Zurzuvae (zuranolone)2023 · FDA new drug approval · Biogen headquarters, CambridgeNew drug approved by the FDA on 2023-08-04. Active ingredient: zuranolone. Sponsor: Biogen. Application NDA217369.FDA Drugs@FDA, application NDA217369 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217369)
Zynyz (retifanlimab-dlwr)2023 · FDA new drug approval · Incyte headquarters, WilmingtonNew drug approved by the FDA on 2023-03-22. Active ingredient: retifanlimab-dlwr. Sponsor: Incyte Corp. Application BLA761334.FDA Drugs@FDA, application BLA761334 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761334)
Alhemo (concizumab-mtci)2024 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2024-12-20. Active ingredient: concizumab-mtci. Sponsor: Novo Nordisk Inc. Application BLA761315.FDA Drugs@FDA, application BLA761315 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761315)
Attruby (acoramidis hydrochloride)2024 · FDA new drug approval · BridgeBio headquarters, Palo AltoNew drug approved by the FDA on 2024-11-22. Active ingredient: acoramidis hydrochloride. Sponsor: Bridgebio Pharma. Application NDA216540.FDA Drugs@FDA, application NDA216540 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216540)
Cobenfy (trospium chloride, xanomeline tartrate)2024 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2024-09-26. Active ingredient: trospium chloride, xanomeline tartrate. Sponsor: Bristol-Myers. Application NDA216158.FDA Drugs@FDA, application NDA216158 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216158)
Crenessity (crinecerfont)2024 · FDA new drug approval · Neurocrine Biosciences headquarters, San DiegoNew drug approved by the FDA on 2024-12-13. Active ingredient: crinecerfont. Sponsor: Neurocrine. Application NDA218808.FDA Drugs@FDA, application NDA218808 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218808)
Ebglyss (lebrikizumab-lbkz)2024 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2024-09-13. Active ingredient: lebrikizumab-lbkz. Sponsor: Eli Lilly And Co. Application BLA761306.FDA Drugs@FDA, application BLA761306 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761306)
Ensacove (ensartinib hydrochloride)2024 · FDA new drug approval · Xcovery (United States) headquarters, Palm Beach GardensNew drug approved by the FDA on 2024-12-18. Active ingredient: ensartinib hydrochloride. Sponsor: Xcovery. Application NDA218171.FDA Drugs@FDA, application NDA218171 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218171)
Hympavzi (marstacimab-hncq)2024 · FDA new drug approval · Pfizer headquarters, New York CityNew drug approved by the FDA on 2024-10-11. Active ingredient: marstacimab-hncq. Sponsor: Pfizer Inc. Application BLA761369.FDA Drugs@FDA, application BLA761369 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761369)
Imdelltra (tarlatamab-dlle)2024 · FDA new drug approval · Amgen headquarters, Thousand OaksNew drug approved by the FDA on 2024-05-16. Active ingredient: tarlatamab-dlle. Sponsor: Amgen Inc. Application BLA761344.FDA Drugs@FDA, application BLA761344 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761344)
Itovebi (inavolisib)2024 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2024-10-10. Active ingredient: inavolisib. Sponsor: Genentech Inc. Application NDA219249.FDA Drugs@FDA, application NDA219249 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219249)
Lazcluze (lazertinib mesylate)2024 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2024-08-19. Active ingredient: lazertinib mesylate. Sponsor: Janssen Biotech. Application NDA219008.FDA Drugs@FDA, application NDA219008 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219008)
Livdelzi (seladelpar lysine)2024 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2024-08-14. Active ingredient: seladelpar lysine. Sponsor: Gilead Sciences Inc. Application NDA217899.FDA Drugs@FDA, application NDA217899 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217899)
Nemluvio (nemolizumab-ilto)2024 · FDA new drug approval · Galderma headquarters, ZugNew drug approved by the FDA on 2024-08-12. Active ingredient: nemolizumab-ilto. Sponsor: Galderma Labs Lp. Application BLA761390.FDA Drugs@FDA, application BLA761390 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761390)
Nemluvio (nemolizumab-ilto)2024 · FDA new drug approval · Galderma headquarters, ZugNew drug approved by the FDA on 2024-12-13. Active ingredient: nemolizumab-ilto. Sponsor: Galderma Labs Lp. Application BLA761391.FDA Drugs@FDA, application BLA761391 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761391)
Niktimvo (axatilimab-csfr)2024 · FDA new drug approval · Incyte headquarters, WilmingtonNew drug approved by the FDA on 2024-08-14. Active ingredient: axatilimab-csfr. Sponsor: Incyte Corp. Application BLA761411.FDA Drugs@FDA, application BLA761411 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761411)
Ohtuvayre (ensifentrine)2024 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2024-06-26. Active ingredient: ensifentrine. Sponsor: Msd. Application NDA217389.FDA Drugs@FDA, application NDA217389 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217389)
Piasky (crovalimab-akkz)2024 · FDA new drug approval · Genentech headquarters, South San FranciscoNew drug approved by the FDA on 2024-06-20. Active ingredient: crovalimab-akkz. Sponsor: Genentech Inc. Application BLA761388.FDA Drugs@FDA, application BLA761388 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761388)
Revuforj (revumenib citrate)2024 · FDA new drug approval · Syndax Pharmaceuticals headquarters, MassachusettsNew drug approved by the FDA on 2024-11-15. Active ingredient: revumenib citrate. Sponsor: Syndax. Application NDA218944.FDA Drugs@FDA, application NDA218944 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218944)
Tevimbra (tislelizumab-jsgr)2024 · FDA new drug approval · BeiGene headquarters, CambridgeNew drug approved by the FDA on 2024-03-13. Active ingredient: tislelizumab-jsgr. Sponsor: Beigene. Application BLA761232.FDA Drugs@FDA, application BLA761232 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761232)
Voranigo (vorasidenib)2024 · FDA new drug approval · Laboratoires Servier headquarters, SuresnesNew drug approved by the FDA on 2024-08-06. Active ingredient: vorasidenib. Sponsor: Servier. Application NDA218784.FDA Drugs@FDA, application NDA218784 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218784)
Vyloy (zolbetuximab-clzb)2024 · FDA new drug approval · Astellas Pharma headquarters, ChūōNew drug approved by the FDA on 2024-10-18. Active ingredient: zolbetuximab-clzb. Sponsor: Astellas. Application BLA761365.FDA Drugs@FDA, application BLA761365 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761365)
Winrevair (sotatercept-csrk)2024 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2024-03-26. Active ingredient: sotatercept-csrk. Sponsor: Merck Sharp Dohme. Application BLA761363.FDA Drugs@FDA, application BLA761363 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761363)
Andembry (garadacimab-gxii)2025 · FDA new drug approval · CSL Behring headquarters, King of PrussiaNew drug approved by the FDA on 2025-06-16. Active ingredient: garadacimab-gxii. Sponsor: Csl Behring Llc. Application BLA761367.FDA Drugs@FDA, application BLA761367 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761367)
Avmapki Fakzynja Co-Pack (Copackaged) (avutometinib potassium, defactinib hydrochloride)2025 · FDA new drug approval · Verastem Oncology headquarters, NeedhamNew drug approved by the FDA on 2025-05-08. Active ingredient: avutometinib potassium, defactinib hydrochloride. Sponsor: Verastem Inc. Application NDA219616.FDA Drugs@FDA, application NDA219616 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219616)
Blujepa (gepotidacin mesylate)2025 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2025-03-25. Active ingredient: gepotidacin mesylate. Sponsor: Glaxosmithkline. Application NDA218230.FDA Drugs@FDA, application NDA218230 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218230)
Brinsupri (brensocatib)2025 · FDA new drug approval · Insmed headquarters, Bridgewater TownshipNew drug approved by the FDA on 2025-08-12. Active ingredient: brensocatib. Sponsor: Insmed Inc. Application NDA217673.FDA Drugs@FDA, application NDA217673 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217673)
Datroway (datopotamab deruxtecan-dlnk)2025 · FDA new drug approval · Daiichi Sankyo headquarters, ChūōNew drug approved by the FDA on 2025-01-17. Active ingredient: datopotamab deruxtecan-dlnk. Sponsor: Daiichi Sankyo Inc. Application BLA761394.FDA Drugs@FDA, application BLA761394 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761394)
Datroway (datopotamab deruxtecan-dlnk)2025 · FDA new drug approval · Daiichi Sankyo headquarters, ChūōNew drug approved by the FDA on 2025-06-23. Active ingredient: datopotamab deruxtecan-dlnk. Sponsor: Daiichi Sankyo Inc. Application BLA761464.FDA Drugs@FDA, application BLA761464 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761464)
Emrelis (telisotuzumab vedotin-tllv)2025 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2025-05-14. Active ingredient: telisotuzumab vedotin-tllv. Sponsor: Abbvie Inc. Application BLA761384.FDA Drugs@FDA, application BLA761384 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761384)
Enflonsia (clesrovimab-cfor)2025 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2025-06-09. Active ingredient: clesrovimab-cfor. Sponsor: Merck Sharp Dohme. Application BLA761432.FDA Drugs@FDA, application BLA761432 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761432)
Exdensur (depemokimab-ulaa)2025 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2025-12-16. Active ingredient: depemokimab-ulaa. Sponsor: Glaxosmithkline Llc. Application BLA761458.FDA Drugs@FDA, application BLA761458 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761458)
Hernexeos (zongertinib)2025 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2025-08-08. Active ingredient: zongertinib. Sponsor: Boehringer Ingelheim. Application NDA219042.FDA Drugs@FDA, application NDA219042 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219042)
Hyrnuo (sevabertinib)2025 · FDA new drug approval · Bayer HealthCare headquarters, LeverkusenNew drug approved by the FDA on 2025-11-19. Active ingredient: sevabertinib. Sponsor: Bayer Healthcare. Application NDA219972.FDA Drugs@FDA, application NDA219972 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219972)
Ibtrozi (taletrectinib adipate)2025 · FDA new drug approval · Nuvation (Canada) headquarters, WaterlooNew drug approved by the FDA on 2025-06-11. Active ingredient: taletrectinib adipate. Sponsor: Nuvation. Application NDA219713.FDA Drugs@FDA, application NDA219713 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219713)
Imaavy (nipocalimab-aahu)2025 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2025-04-29. Active ingredient: nipocalimab-aahu. Sponsor: Janssen Biotech. Application BLA761430.FDA Drugs@FDA, application BLA761430 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761430)
Inluriyo (imlunestrant tosylate)2025 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2025-09-25. Active ingredient: imlunestrant tosylate. Sponsor: Eli Lilly And Co. Application NDA218881.FDA Drugs@FDA, application NDA218881 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218881)
Jascayd (nerandomilast)2025 · FDA new drug approval · Boehringer Ingelheim headquarters, Ingelheim am RheinNew drug approved by the FDA on 2025-10-07. Active ingredient: nerandomilast. Sponsor: Boehringer Ingelheim. Application NDA218764.FDA Drugs@FDA, application NDA218764 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218764)
Keytruda Qlex (berahyaluronidase alfa-pmph, pembrolizumab)2025 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2025-09-19. Active ingredient: berahyaluronidase alfa-pmph, pembrolizumab. Sponsor: Merck Sharp Dohme. Application BLA761467.FDA Drugs@FDA, application BLA761467 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761467)
Kygevvi (doxecitine, doxribtimine)2025 · FDA new drug approval · UCB headquarters, Brussels metropolitan areaNew drug approved by the FDA on 2025-11-03. Active ingredient: doxecitine, doxribtimine. Sponsor: Ucb Inc. Application NDA219792.FDA Drugs@FDA, application NDA219792 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219792)
Modeyso (dordaviprone hydrochloride)2025 · FDA new drug approval · Chimerix (United States) headquarters, DurhamNew drug approved by the FDA on 2025-08-06. Active ingredient: dordaviprone hydrochloride. Sponsor: Chimerix. Application NDA219876.FDA Drugs@FDA, application NDA219876 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219876)
Myqorzo (aficamten)2025 · FDA new drug approval · Cytokinetics headquarters, South San FranciscoNew drug approved by the FDA on 2025-12-19. Active ingredient: aficamten. Sponsor: Cytokinetics. Application NDA219083.FDA Drugs@FDA, application NDA219083 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219083)
Palsonify (paltusotine hydrochloride)2025 · FDA new drug approval · Crinetics Pharmaceuticals headquarters, San DiegoNew drug approved by the FDA on 2025-09-25. Active ingredient: paltusotine hydrochloride. Sponsor: Crinetics. Application NDA219070.FDA Drugs@FDA, application NDA219070 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219070)
Penpulimab-Kcqx (penpulimab-kcqx)2025 · FDA new drug approval · Akeso headquarters, GuangzhouNew drug approved by the FDA on 2025-04-23. Active ingredient: penpulimab-kcqx. Sponsor: Akeso Biopharma. Application BLA761258.FDA Drugs@FDA, application BLA761258 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761258)
Qfitlia (fitusiran sodium)2025 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2025-03-28. Active ingredient: fitusiran sodium. Sponsor: Genzyme Corp. Application NDA219019.FDA Drugs@FDA, application NDA219019 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219019)
Rhapsido (remibrutinib)2025 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2025-09-30. Active ingredient: remibrutinib. Sponsor: Novartis. Application NDA218436.FDA Drugs@FDA, application NDA218436 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218436)
Sephience (sepiapterin)2025 · FDA new drug approval · PTC Therapeutics headquarters, South PlainfieldNew drug approved by the FDA on 2025-07-28. Active ingredient: sepiapterin. Sponsor: Ptc Therap. Application NDA219666.FDA Drugs@FDA, application NDA219666 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219666)
Tryptyr (acoltremon)2025 · FDA new drug approval · Alcon headquarters, GenevaNew drug approved by the FDA on 2025-05-28. Active ingredient: acoltremon. Sponsor: Alcon Labs Inc. Application NDA217370.FDA Drugs@FDA, application NDA217370 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217370)
Vanrafia (atrasentan hydrochloride)2025 · FDA new drug approval · Novartis headquarters, BaselNew drug approved by the FDA on 2025-04-02. Active ingredient: atrasentan hydrochloride. Sponsor: Novartis. Application NDA219208.FDA Drugs@FDA, application NDA219208 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219208)
Voyxact (sibeprenlimab-szsi)2025 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 2025-11-25. Active ingredient: sibeprenlimab-szsi. Sponsor: Otsuka Pharm Co Ltd. Application BLA761434.FDA Drugs@FDA, application BLA761434 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761434)
Wayrilz (rilzabrutinib)2025 · FDA new drug approval · Genzyme headquarters, CambridgeNew drug approved by the FDA on 2025-08-29. Active ingredient: rilzabrutinib. Sponsor: Genzyme Corp. Application NDA219685.FDA Drugs@FDA, application NDA219685 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219685)
Yartemlea (narsoplimab-wuug)2025 · FDA new drug approval · Omeros Corporation headquarters, SeattleNew drug approved by the FDA on 2025-12-23. Active ingredient: narsoplimab-wuug. Sponsor: Omeros Corp. Application BLA761152.FDA Drugs@FDA, application BLA761152 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761152)
Ambelvist (gadoquatrane)2026 · FDA new drug approval · Bayer HealthCare headquarters, LeverkusenNew drug approved by the FDA on 2026-06-12. Active ingredient: gadoquatrane. Sponsor: Bayer Healthcare. Application NDA219627.FDA Drugs@FDA, application NDA219627 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219627)
Avlayah (tividenofusp alfa-eknm)2026 · FDA new drug approval · Denali Therapeutics (United States) headquarters, South San FranciscoNew drug approved by the FDA on 2026-03-24. Active ingredient: tividenofusp alfa-eknm. Sponsor: Denali Therapeutics Inc.. Application BLA761485.FDA Drugs@FDA, application BLA761485 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761485)
Awiqli Flextouch (insulin icodec)2026 · FDA new drug approval · Novo headquarters, BagsværdNew drug approved by the FDA on 2026-03-26. Active ingredient: insulin icodec. Sponsor: Novo Nordisk Inc. Application BLA761326.FDA Drugs@FDA, application BLA761326 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761326)
Baxfendy (baxdrostat)2026 · FDA new drug approval · AstraZeneca AB headquarters, SödertäljeNew drug approved by the FDA on 2026-05-15. Active ingredient: baxdrostat. Sponsor: Astrazeneca Ab. Application NDA219878.FDA Drugs@FDA, application NDA219878 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219878)
Decnupaz (pivekimab sunirine-pvzy)2026 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2026-05-27. Active ingredient: pivekimab sunirine-pvzy. Sponsor: Abbvie Inc. Application BLA761460.FDA Drugs@FDA, application BLA761460 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761460)
Etcamah (camizestrant)2026 · FDA new drug approval · AstraZeneca headquarters, CambridgeNew drug approved by the FDA on 2026-09-04. Active ingredient: camizestrant. Sponsor: Astrazeneca. Application NDA220359.FDA Drugs@FDA, application NDA220359 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220359)
Foundayo (orforglipron calcium)2026 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2026-04-01. Active ingredient: orforglipron calcium. Sponsor: Eli Lilly And Co. Application NDA220934.FDA Drugs@FDA, application NDA220934 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220934)
Hepcludex (bulevirtide-gmod)2026 · FDA new drug approval · Gilead Sciences headquarters, Foster CityNew drug approved by the FDA on 2026-05-22. Active ingredient: bulevirtide-gmod. Sponsor: Gilead Sciences Inc. Application BLA761468.FDA Drugs@FDA, application BLA761468 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761468)
Hibsago (bepirovirsen)2026 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2026-10-20. Active ingredient: bepirovirsen. Sponsor: Glaxosmithkline Llc. Application NDA221276.FDA Drugs@FDA, application NDA221276 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=221276)
Icotyde (icotrokinra hydrochloride)2026 · FDA new drug approval · Janssen Biotech headquarters, HorshamNew drug approved by the FDA on 2026-03-17. Active ingredient: icotrokinra hydrochloride. Sponsor: Janssen Biotech. Application NDA220149.FDA Drugs@FDA, application NDA220149 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220149)
Juvmo (tavapadon)2026 · FDA new drug approval · AbbVie headquarters, North ChicagoNew drug approved by the FDA on 2026-09-25. Active ingredient: tavapadon. Sponsor: Abbvie. Application NDA220415.FDA Drugs@FDA, application NDA220415 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220415)
Lifyorli (Copackaged) (relacorilant)2026 · FDA new drug approval · Corcept Therapeutics headquarters, Menlo ParkNew drug approved by the FDA on 2026-03-25. Active ingredient: relacorilant. Sponsor: Corcept Therap. Application NDA220641.FDA Drugs@FDA, application NDA220641 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220641)
Lipfendra (enlicitide decanoate)2026 · FDA new drug approval · Merck & Co. headquarters, KenilworthNew drug approved by the FDA on 2026-07-15. Active ingredient: enlicitide decanoate. Sponsor: Msd. Application NDA220848.FDA Drugs@FDA, application NDA220848 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220848)
Onswik (insulin efsitora alfa-gobe)2026 · FDA new drug approval · Eli Lilly and Company headquarters, IndianapolisNew drug approved by the FDA on 2026-09-23. Active ingredient: insulin efsitora alfa-gobe. Sponsor: Eli Lilly And Co. Application BLA761408.FDA Drugs@FDA, application BLA761408 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761408)
Pasatru (garetosmab-grts)2026 · FDA new drug approval · Regeneron Pharmaceuticals headquarters, EastviewNew drug approved by the FDA on 2026-08-19. Active ingredient: garetosmab-grts. Sponsor: Regeneron Pharmaceuticals, Inc. Application BLA761508.FDA Drugs@FDA, application BLA761508 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761508)
Rasonque (daraxonrasib)2026 · FDA new drug approval · Revolution Medicines (United States) headquarters, Redwood CityNew drug approved by the FDA on 2026-08-26. Active ingredient: daraxonrasib. Sponsor: Revolution Medicines. Application NDA220910.FDA Drugs@FDA, application NDA220910 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220910)
Simtriyo (centanafadine hydrochloride)2026 · FDA new drug approval · Otsuka Pharmaceutical headquarters, ChiyodaNew drug approved by the FDA on 2026-07-24. Active ingredient: centanafadine hydrochloride. Sponsor: Otsuka Pharmaceutical Co Ltd. Application NDA218145.FDA Drugs@FDA, application NDA218145 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218145)
Utebzi (tebipenem pivoxil hydrobromide)2026 · FDA new drug approval · GSK headquarters, LondonNew drug approved by the FDA on 2026-06-17. Active ingredient: tebipenem pivoxil hydrobromide. Sponsor: Glaxosmithkline. Application NDA215960.FDA Drugs@FDA, application NDA215960 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215960)
Xocova (ensitrelvir)2026 · FDA new drug approval · Shionogi headquarters, Chūō-kuNew drug approved by the FDA on 2026-05-29. Active ingredient: ensitrelvir. Sponsor: Shionogi. Application NDA220442.FDA Drugs@FDA, application NDA220442 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220442)
Zenbexus (iberdomide hydrochloride)2026 · FDA new drug approval · Bristol-Myers Squibb headquarters, New York CityNew drug approved by the FDA on 2026-08-13. Active ingredient: iberdomide hydrochloride. Sponsor: Bristol Myers Squibb. Application NDA221075.FDA Drugs@FDA, application NDA221075 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=221075)

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