Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 16 new drug or biologic applications and 19 efficacy supplements (new uses for approved drugs) in July 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 16
Jul 7: the FDA approved Trutakna (atacicept), Vera Therapeutics Inc., BLA761486 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 9: the FDA approved Sarclisa Escena (isatuximab-irfc), Sanofi-Aventis U.S. Llc, BLA761445 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jul 9: the FDA approved Sodium Bicarbonate, Amneal, NDA220790 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jul 10: the FDA approved Zyogreen (indocyanine green), Provepharm Sas, NDA218579 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jul 14: the FDA approved Revtorpyk (gedatolisib), Celcuity, NDA219908 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 15: the FDA approved Lipfendra, Msd, NDA220848 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 19: the FDA approved Air, Noble Gas Solutions Inc., NDA221805 ORIG-1. FDA letter.
Jul 22: the FDA approved Jideytro (zidesamtinib), Nuvalent, NDA220185 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 24: the FDA approved Garzulys (insulin aspart-fsan), Emerge Bioscience Pte. Ltd., BLA761497 ORIG-1. FDA letter.
Jul 24: the FDA approved Lytenava (bevacizumab-vikg), Outlook Therapeutics, Inc., BLA761320 ORIG-1 (Type 1 - New Molecular Entity and Type 4 - New Combination). FDA letter.
Jul 24: the FDA approved Simtriyo (centanafadine hydrochloride), Otsuka Pharmaceutical Co Ltd, NDA218145 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jul 24: the FDA approved Tylenol With Naproxen (acetaminophen, naproxen sodium), Kenvue Brands, NDA219962 ORIG-1 (Type 4 - New Combination). FDA letter.
Jul 28: the FDA approved Gwyn Lo (norelgestromin and ethinyl estradiol), Viatris Specialty, NDA219990 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jul 29: the FDA approved Glycophos (sodium glycerophosphate), Fresenius Kabi Usa, NDA220381 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
Jul 29: the FDA approved Qlonilik (clonidine hydrochloride), Cmp Dev Llc, NDA221094 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jul 31: the FDA approved Zimrixby (rituximab-cdxx), Dr Reddys Labs Sa, BLA761376 ORIG-1. FDA letter.
New uses for approved drugs (efficacy supplements) · 19
Jul 1: the FDA approved an efficacy supplement for Kisqali (ribociclib), Novartis, NDA209092 SUPPL-27. FDA letter.
Jul 1: the FDA approved an efficacy supplement for Kisqali Femara Co-Pack (Copackaged) (letrozole, ribociclib succinate), Novartis, NDA209935 SUPPL-33. FDA letter.
Jul 7: the FDA approved an efficacy supplement for Ryaltris (olopatadine hydrochloride and mometasone furoate), Glenmark Speclt, NDA211746 SUPPL-11. FDA letter.
Jul 10: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-194. FDA letter.
Jul 10: the FDA approved an efficacy supplement for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 SUPPL-12. FDA letter.
Jul 10: the FDA approved an efficacy supplement for Padcev Ejfv (enfortumab vedotin), Astellas, BLA761137 SUPPL-37. FDA letter.
Jul 13: the FDA approved an efficacy supplement for Lecanemab Autoinjector (lecanemab-irmb), Eisai Inc, BLA761375 SUPPL-1. FDA letter.
Jul 13: the FDA approved an efficacy supplement for Verzenio (abemaciclib), Eli Lilly And Co, NDA208716 SUPPL-21. FDA letter.
Jul 14: the FDA approved an efficacy supplement for Retevmo (selpercatinib), Eli Lilly And Co, NDA218160 SUPPL-7. FDA letter.
Jul 14: the FDA approved an efficacy supplement for Retevmo (selpercatinib), Eli Lilly And Co, NDA213246 SUPPL-17. FDA letter.
Jul 16: the FDA approved an efficacy supplement for Fabhalta (iptacopan), Novartis, NDA218276 SUPPL-7. FDA letter.
Jul 16: the FDA approved an efficacy supplement for Ilumya (tildrakizumab-asmn), Sun Pharma Global, BLA761067 SUPPL-27. FDA letter.
Jul 16: the FDA approved an efficacy supplement for Rezzayo (rezafungin), Mundipharma, NDA217417 SUPPL-7. FDA letter.
Jul 23: the FDA approved an efficacy supplement for Furoscix (furosemide injection 80 mg/ 10 ml), Scpharmaceuticals, NDA209988 SUPPL-7. FDA letter.
Jul 23: the FDA approved an efficacy supplement for Macrilen (macimorelin acetate), Aeterna Zentaris, NDA205598 SUPPL-5. FDA letter.
Jul 24: the FDA approved an efficacy supplement for Idkit Hp One (citric acid anhydrous and 13c urea), Meridian Bioscience, NDA021314 SUPPL-14. FDA letter.
Jul 24: the FDA approved an efficacy supplement for Xtandi (enzalutamide), Astellas, NDA203415 SUPPL-26. FDA letter.
Jul 24: the FDA approved an efficacy supplement for Xtandi (enzalutamide), Astellas, NDA213674 SUPPL-16. FDA letter.
Jul 31: the FDA approved an efficacy supplement for Pluvicto (lutetium lu 177 vipivotide tetraxetan), Novartis, NDA215833 SUPPL-37. 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 2026 · August 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026