Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 8 new drug or biologic applications and 22 efficacy supplements (new uses for approved drugs) in May 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 8
May 8: the FDA approved Avmapki Fakzynja Co-Pack (avutometinib potassium and defactinib hydrochloride), Verastem Inc, NDA219616 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 14: the FDA approved Brekiya (dihydroergotamine mesylate), Amneal, NDA215400 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
May 14: the FDA approved Emrelis (telisotuzumab vedotin), Abbvie Inc, BLA761384 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 22: the FDA approved Starjemza (ustekinumab-hmny), Bio-Thera Solutions Ltd, BLA761419 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
May 23: the FDA approved Yutrepia (treprostinil), Liquidia Tech, NDA213005 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
May 28: the FDA approved Khindivi (hydrocortisone), Eton, NDA218980 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
May 28: the FDA approved Tryptyr (acoltremon), Alcon Labs Inc, NDA217370 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
May 30: the FDA approved Phenylephrine Hydrochloride Injection, Solution, Dr Reddys Labs Sa, NDA216830 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
New uses for approved drugs (efficacy supplements) · 22
May 9: the FDA approved an efficacy supplement for Optison Perflutren Protein-Type A Microspheres (human albumin microspheres and perflutren), Ge Healthcare, NDA020899 SUPPL-25. FDA letter.
May 9: the FDA approved an efficacy supplement for Rexulti (brexpiprazole), Otsuka, NDA205422 SUPPL-14. FDA letter.
May 14: the FDA approved an efficacy supplement for Kadcyla (ado-trastuzumab emtansine), Genentech, BLA125427 SUPPL-121. FDA letter.
May 14: the FDA approved an efficacy supplement for Welireg (belzutifan), Merck Sharp Dohme, NDA215383 SUPPL-12. FDA letter.
May 15: the FDA approved an efficacy supplement for Zynyz (retifanlimab-dlwr), Incyte Corp, BLA761334 SUPPL-4. FDA letter.
May 20: the FDA approved an efficacy supplement for Adalimumab-Adbm, Boehringer Ingelheim, BLA761058 SUPPL-31. FDA letter.
May 20: the FDA approved an efficacy supplement for Amjevita (adalimumab-atto), Amgen Inc, BLA761024 SUPPL-21. FDA letter.
May 21: the FDA approved an efficacy supplement for Susvimo (ranibizumab), Genentech Inc, BLA761197 SUPPL-7. FDA letter.
May 22: the FDA approved an efficacy supplement for Kalydeco (ivacaftor), Vertex Pharms Inc, NDA207925 SUPPL-19. FDA letter.
May 22: the FDA approved an efficacy supplement for Kalydeco (ivacaftor), Vertex Pharms, NDA203188 SUPPL-41. FDA letter.
May 22: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-182. FDA letter.
May 22: the FDA approved an efficacy supplement for Kyprolis (carfilzomib), Onyx Pharms Amgen, NDA202714 SUPPL-36. FDA letter.
May 22: the FDA approved an efficacy supplement for Lupron Depot-Ped (leuprolide acetate), Abbvie Endocrine Inc, NDA020263 SUPPL-56. FDA letter.
May 22: the FDA approved an efficacy supplement for Nucala (mepolizumab), Glaxosmithkline Llc, BLA125526 SUPPL-7. FDA letter.
May 22: the FDA approved an efficacy supplement for Prolia (denosumab), Amgen, BLA125320 SUPPL-219. FDA letter.
May 22: the FDA approved an efficacy supplement for Zoryve (roflumilast), Arcutis, NDA217242 SUPPL-5. FDA letter.
May 23: the FDA approved an efficacy supplement for Opdivo (nivolumab), Bristol Myers Squibb, BLA125554 SUPPL-133. FDA letter.
May 23: the FDA approved an efficacy supplement for Yervoy (ipilimumab), Bristol Myers Squibb, BLA125377 SUPPL-136.
May 28: the FDA approved an efficacy supplement for Spevigo (spesolimab-sbzo), Boehringer Ingelheim Pharmaceuticals Inc, BLA761244 SUPPL-4. FDA letter.
May 30: the FDA approved an efficacy supplement for Xenoview (xenon xe 129 hyperpolarized), Polarean, NDA214375 SUPPL-1. FDA letter.
May 30: the FDA approved an efficacy supplement for Xofluza (baloxavir marboxil), Genentech Inc, NDA214410 SUPPL-8. FDA letter.
May 30: the FDA approved an efficacy supplement for Xofluza (baloxavir marboxil), Genentech Inc, NDA210854 SUPPL-23. FDA letter.
Source: openFDA drugsfda (the Drugs@FDA data), read 2026-11-12. openFDA trails Drugs@FDA by about a week, so the latest days of a month can be missing until the next read. Generic approvals (ANDAs), labeling-only and manufacturing supplements are not listed. ← April 2025 · June 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025