Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 15 new drug or biologic applications and 17 efficacy supplements (new uses for approved drugs) in July 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 15
Jul 2: the FDA approved Lynozyfic (linvoseltamab-gcpt), Rengeneron Pharmaceuticals, Inc., BLA761400 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 2: the FDA approved Zegfrovy (sunvozertinib), Dizal, NDA219839 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 3: the FDA approved Bendamustine Hydrochloride, Avyxa Holdings, NDA219014 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jul 3: the FDA approved Ekterly (sebetralstat), Kalvista, NDA219301 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 15: the FDA approved Insulin Diluting Medium For Kirsty (water), Biocon Biologics Inc, BLA761188 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jul 16: the FDA approved Famotidine, Sagent, NDA219935 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jul 23: the FDA approved Anzupgo (delgocitinib), Leo Pharma As, NDA219155 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 23: the FDA approved Vostally (ramipril), Rosemont Pharms, NDA219757 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jul 24: the FDA approved Doptelet Sprinkle (avatrombopag), Akarx Inc, NDA219696 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jul 24: the FDA approved Sdamlo (amlodipine), Brillian Pharma, NDA219531 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jul 28: the FDA approved Sephience (sepiapterin), Ptc Therap, NDA219666 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 29: the FDA approved Vyscoxa (celecoxib), Carwin Pharm Assoc, NDA211759 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jul 30: the FDA approved Atmeksi (methocarbamol), Rosemont Pharms, NDA219843 ORIG-1. FDA letter.
Jul 31: the FDA approved Alhemo (concizumab), Novo Nordisk Inc, BLA761428 ORIG-1 (Type 9 - New indication submitted as distinct BLA, consolidated). FDA letter.
Jul 31: the FDA approved Vizz (aceclidine), Lenz Therap, NDA218585 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
New uses for approved drugs (efficacy supplements) · 17
Jul 1: the FDA approved an efficacy supplement for Kisunla (donanemab-azbt), Eli Lilly Co, BLA761248 SUPPL-4. FDA letter.
Jul 3: the FDA approved an efficacy supplement for Isturisa (osilodrostat), Recordati Rare, NDA212801 SUPPL-4. FDA letter.
Jul 10: the FDA approved an efficacy supplement for Elrexfio (elranatamab-bcmm), Pfizer Inc, BLA761345 SUPPL-3. FDA letter.
Jul 10: the FDA approved an efficacy supplement for Motegrity (prucalopride), Takeda Pharms Usa, NDA210166 SUPPL-4. FDA letter.
Jul 11: the FDA approved an efficacy supplement for Kerendia (finerenone), Bayer Hlthcare, NDA215341 SUPPL-9. FDA letter.
Jul 16: the FDA approved an efficacy supplement for Glycopyrrolate, Fresenius Kabi Usa, NDA214919 SUPPL-2. FDA letter.
Jul 16: the FDA approved an efficacy supplement for Glycopyrrolate, Hikma, NDA017558 SUPPL-68. FDA letter.
Jul 16: the FDA approved an efficacy supplement for Glyrx-Pf (glycopyrrolate), Exela Pharma, NDA210997 SUPPL-8. FDA letter.
Jul 23: the FDA approved an efficacy supplement for Otezla (apremilast), Amgen Inc, NDA205437 SUPPL-14. FDA letter.
Jul 23: the FDA approved an efficacy supplement for Sotalol Hydrochloride, Altathera Pharms Llc, NDA022306 SUPPL-8. FDA letter.
Jul 24: the FDA approved an efficacy supplement for Doptelet (avatrombopag maleate), Akarx Inc, NDA210238 SUPPL-10. FDA letter.
Jul 24: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-178. FDA letter.
Jul 25: the FDA approved an efficacy supplement for Skytrofa (lonapegsomatropin-tcgd), Ascendis Pharma Encocrinology Div A/S, BLA761177 SUPPL-8. FDA letter.
Jul 28: the FDA approved an efficacy supplement for Empaveli (pegcetacoplan), Apellis Pharms, NDA215014 SUPPL-11. FDA letter.
Jul 28: the FDA approved an efficacy supplement for Sirturo (bedaquiline fumarate), Janssen Therap, NDA204384 SUPPL-20. FDA letter.
Jul 30: the FDA approved an efficacy supplement for Biktarvy (bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate), Gilead Sciences Inc, NDA210251 SUPPL-23. FDA letter.
Jul 31: the FDA approved an efficacy supplement for Leqvio (inclisiran), Novartis, NDA214012 SUPPL-16. 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. ← June 2025 · August 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025