FDA approvals, March 2026

The FDA approved 10 new drug or biologic applications and 20 efficacy supplements (new uses for approved drugs) in March 2026, per Drugs@FDA as read on 2026-11-12.

New drug and biologic applications · 10

• Mar 6: the FDA approved Pylarify Truvu (piflufolastat f-18), Aphelion, NDA220089 ORIG-1 (Type 5 - New Formulation or New Manufacturer).
• Mar 17: the FDA approved Icotyde (icotrokinra), Janssen Biotech, NDA220149 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Mar 17: the FDA approved Lynavoy (linerixibat), Intercept, NDA220295 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Mar 19: the FDA approved Flavalta (lidocaine hydrochloride and epinephrine), Deproco, NDA216564 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Mar 20: the FDA approved Atomoxetine Hydrochloride, Map77, NDA220320 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
• Mar 24: the FDA approved Avlayah (tividenofusp alfa-eknm), Denali Therapeutics Inc., BLA761485 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Mar 25: the FDA approved Lifyorli (relacorilant), Corcept Therap, NDA220641 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Mar 26: the FDA approved Awiqli Flextouch (insulin icodec), Novo Nordisk Inc, BLA761326 ORIG-2 (Type 1 - New Molecular Entity). FDA letter.
• Mar 27: the FDA approved Ponlimsi (denosumab-adet), Teva Pharmaceuticals, Inc., BLA761385 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Mar 30: the FDA approved Epinephrine, Baxter Hlthcare Corp, NDA220626 ORIG-1 (New Combination and New Formulation or New Manufacturer). FDA letter.

New uses for approved drugs (efficacy supplements) · 20

• Mar 5: the FDA approved an efficacy supplement for Tecvayli (teclistamab-cqyv), Janssen Biotech, BLA761291 SUPPL-18. FDA letter.
• Mar 6: the FDA approved an efficacy supplement for Skyrizi (risankizumab-rzaa), Abbvie Inc, BLA761105 SUPPL-42. FDA letter.
• Mar 6: the FDA approved an efficacy supplement for Sotyktu (deucravacitinib), Bristol, NDA214958 SUPPL-2. FDA letter.
• Mar 6: the FDA approved an efficacy supplement for Xeljanz (tofacitinib), Pfizer, NDA213082 SUPPL-13. FDA letter.
• Mar 6: the FDA approved an efficacy supplement for Xeljanz (tofacitinib), Pf Prism Cv, NDA203214 SUPPL-41. FDA letter.
• Mar 6: the FDA approved an efficacy supplement for Xeljanz Xr (tofacitinib), Pfizer, NDA208246 SUPPL-27. FDA letter.
• Mar 9: the FDA approved an efficacy supplement for Wellcovorin (leucovorin calcium), Glaxosmithkline, NDA018342 SUPPL-15. FDA letter.
• Mar 12: the FDA approved an efficacy supplement for Cosentyx (secukinumab), Novartis Pharms Corp, BLA125504 SUPPL-91. FDA letter.
• Mar 19: the FDA approved an efficacy supplement for Imcivree (setmelanotide), Rhythm, NDA213793 SUPPL-9. FDA letter.
• Mar 19: the FDA approved an efficacy supplement for Wegovy (semaglutide), Novo, NDA215256 SUPPL-29. FDA letter.
• Mar 20: the FDA approved an efficacy supplement for Opdivo (nivolumab), Bristol Myers Squibb, BLA125554 SUPPL-135. FDA letter.
• Mar 26: the FDA approved an efficacy supplement for Neffy (epinephrine), Ars Pharms Operation, NDA214697 SUPPL-2. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor), Vertex Pharms Inc, NDA218730 SUPPL-1. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Daybue (trofinetide), Acadia Pharms Inc, NDA217026 SUPPL-8. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Epkinly (epcoritamab-bysp), Genmab Us, Inc., BLA761324 SUPPL-10. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Licart (diclofenac epolamine), Ibsa Inst Bio, NDA206976 SUPPL-18. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Spinraza (nusinersen), Biogen, NDA209531 SUPPL-16. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Trikafta (elexacaftor, tezacaftor, and ivacaftor), Vertex Pharms Inc, NDA217660 SUPPL-8. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Trikafta (elexacaftor, tezacaftor, and ivacaftor), Vertex Pharms Inc, NDA212273 SUPPL-14. FDA letter.
• Mar 30: the FDA approved an efficacy supplement for Zynyz (retifanlimab-dlwr), Incyte Corp, BLA761334 SUPPL-8. 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. ← February 2026 · April 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026