FDA approvals, October 2026

The FDA approved 16 new drug or biologic applications and 25 efficacy supplements (new uses for approved drugs) in October 2026, per Drugs@FDA as read on 2026-11-12.

New drug and biologic applications · 16

• Oct 1: the FDA approved Trabectedin, Ever, NDA219617 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Oct 8: the FDA approved Breztri Aerosphere (budesonide, formoterol fumarate, glycopyrrolate), Astrazeneca Ab, NDA220290 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Oct 8: the FDA approved Weltruza (olanzapine), Teva, NDA219007 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Oct 9: the FDA approved Hovilpri (pritelivir mesylate), Aicuris Anti-Infect, NDA221154 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Oct 9: the FDA approved Isovue Readi (iopamidol), Bracco, NDA220583 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Oct 15: the FDA approved Evoxac (cevimeline hydrochloride), Cosette, NDA221183 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
• Oct 16: the FDA approved Brytly (apraclonidine hydrochloride), Alcon Labs Inc, NDA220341 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Oct 16: the FDA approved Yulzety (rivaroxaban), Rosemont Pharms, NDA221033 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
• Oct 19: the FDA approved Calrezdy (calcuim chloride), Fresenius Medcl Care, NDA219456 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
• Oct 19: the FDA approved Cienby (sodium ctirate), Fresenius Medcl Care, NDA219455 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
• Oct 20: the FDA approved Hibsago (bepirovirsen), Glaxosmithkline Llc, NDA221276 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Oct 22: the FDA approved Ahzantive (aflibercept-mrbb), Formycon Ag, BLA761378 ORIG-2 (Type 3 - New Dosage Form). FDA letter.
• Oct 22: the FDA approved Enzeevu (aflibercept), Sandoz Inc, BLA761382 ORIG-2. FDA letter.
• Oct 22: the FDA approved Pavblu (aflibercept-ayyh), Amgen Inc, BLA761298 ORIG-2. FDA letter.
• Oct 27: the FDA approved Ranibizumab, Xbrane Biopharma Ab, BLA761187 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
• Oct 29: the FDA approved Axycis (cisplatin), Avyxa Holdings, Llc., NDA220748 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.

New uses for approved drugs (efficacy supplements) · 25

• Oct 2: the FDA approved an efficacy supplement for Jaypirca (pirtobrutinib), Loxo Oncol, NDA216059 SUPPL-6. FDA letter.
• Oct 6: the FDA approved an efficacy supplement for Rhapsido (remibrutinib), Novartis, NDA218436 SUPPL-1. FDA letter.
• Oct 7: the FDA approved an efficacy supplement for Tukysa (tucatinib), Seagen, NDA213411 SUPPL-10. FDA letter.
• Oct 8: the FDA approved an efficacy supplement for Tecentriq (atezolizumab), Genentech Inc, BLA761034 SUPPL-65. FDA letter.
• Oct 8: the FDA approved an efficacy supplement for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), Genentech Inc, BLA761347 SUPPL-11. FDA letter.
• Oct 9: the FDA approved an efficacy supplement for Olumiant (baricitinib), Eli Lilly And Co, NDA207924 SUPPL-10. FDA letter.
• Oct 9: the FDA approved an efficacy supplement for Repatha (evolocumab), Amgen Inc, BLA125522 SUPPL-47. FDA letter.
• Oct 13: the FDA approved an efficacy supplement for Velphoro (sucroferric oxyhydroxide), Vifor Fresenius, NDA205109 SUPPL-14. FDA letter.
• Oct 14: the FDA approved an efficacy supplement for Anktiva (nogapendekin alfa inbakicept-pmln), Altor Bioscience, Llc, An Indirect Wholly-Owned Su, BLA761336 SUPPL-2. FDA letter.
• Oct 14: the FDA approved an efficacy supplement for Enflonsia (clesrovimab), Merck Sharp Dohme, BLA761432 SUPPL-3. FDA letter.
• Oct 15: the FDA approved an efficacy supplement for Cosentyx (secukinumab), Novartis Pharms Corp, BLA761349 SUPPL-13. FDA letter.
• Oct 15: the FDA approved an efficacy supplement for Enspryng (satralizumab), Genentech, BLA761149 SUPPL-8. FDA letter.
• Oct 15: the FDA approved an efficacy supplement for Zilbrysq (zilucoplan sodium), Ucb Inc, NDA216834 SUPPL-15. FDA letter.
• Oct 16: the FDA approved an efficacy supplement for Ayvakit (avapritinib), Blueprint Medicines, NDA212608 SUPPL-21. FDA letter.
• Oct 16: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-191. FDA letter.
• Oct 16: the FDA approved an efficacy supplement for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 SUPPL-8.
• Oct 16: the FDA approved an efficacy supplement for Ryzumvi (phentolamine mesylate), Famygen Life Sci, NDA217064 SUPPL-5. FDA letter.
• Oct 19: the FDA approved an efficacy supplement for Jemperli (dostarlimab), Glaxosmithkline, BLA761174 SUPPL-15. FDA letter.
• Oct 21: the FDA approved an efficacy supplement for Ultomiris (ravulizumab), Alexion Pharm, BLA761108 SUPPL-46. FDA letter.
• Oct 23: the FDA approved an efficacy supplement for Awiqli Flextouch (insulin icodec), Novo Nordisk Inc, BLA761326 SUPPL-1. FDA letter.
• Oct 23: the FDA approved an efficacy supplement for Monoferric (ferric derisomaltose), Pharmacosmos, NDA208171 SUPPL-6. FDA letter.
• Oct 23: the FDA approved an efficacy supplement for Skyrizi (risankizumab-rzaa), Abbvie Inc, BLA761105 SUPPL-53. FDA letter.
• Oct 26: the FDA approved an efficacy supplement for Talzenna (talazoparib), Pfizer, NDA217439 SUPPL-4. FDA letter.
• Oct 26: the FDA approved an efficacy supplement for Talzenna (talazoparib), Pfizer, NDA211651 SUPPL-14. FDA letter.
• Oct 29: the FDA approved an efficacy supplement for Ilumya (tildrakizumab-asmn), Sun Pharma Global, BLA761067 SUPPL-31. 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. ← September 2026 · November 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026