Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 7 new drug or biologic applications and 22 efficacy supplements (new uses for approved drugs) in June 2026, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 7
Jun 2: the FDA approved Ranluspec (ranibizumab-hkdz), Lupin Limited, BLA761480 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
Jun 2: the FDA approved Tiocystin (tiopronin), Casper Pharma Llc, NDA212927 ORIG-1 (Type 5 - New Formulation or New Manufacturer).
Jun 12: the FDA approved Ambelvist (gadoquatrane), Bayer Healthcare, NDA219627 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jun 16: the FDA approved Aprepitant, Azurity, NDA218754 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jun 17: the FDA approved Utebzi (tebipenem pivoxil), Glaxosmithkline, NDA215960 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jun 24: the FDA approved Navitrux (fosaprepitant), Avyxa Holdings, NDA220436 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jun 26: the FDA approved Lumvoa (veligrotug), Viridian Therapeutics Inc, BLA761530 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
New uses for approved drugs (efficacy supplements) · 22
Jun 5: the FDA approved an efficacy supplement for Hympavzi (marstacimab-hncq), Pfizer Inc, BLA761369 SUPPL-3. FDA letter.
Jun 9: the FDA approved an efficacy supplement for Ebglyss (lebrikizumab-lbkz), Eli Lilly And Co, BLA761306 SUPPL-6. FDA letter.
Jun 11: the FDA approved an efficacy supplement for Alecensa (alectinib hydrochloride), Hoffmann-La Roche, NDA208434 SUPPL-16. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-192. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 SUPPL-9. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Skyrizi (risankizumab-rzaa), Abbvie Inc, BLA761105 SUPPL-44. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Truqap (capivasertib), Astrazeneca, NDA218197 SUPPL-4. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Tzield (teplizumab-mzwv), Provention Bio Inc, BLA761183 SUPPL-10. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Welireg (belzutifan), Merck Sharp Dohme, NDA215383 SUPPL-15. FDA letter.
Jun 16: the FDA approved an efficacy supplement for Rextovy (naloxone hydrochloride), Amphastar Pharms Inc, NDA208969 SUPPL-2. FDA letter.
Jun 18: the FDA approved an efficacy supplement for Zegalogue (dasiglucagon), Zealand Pharma, NDA214231 SUPPL-4. FDA letter.
Jun 24: the FDA approved an efficacy supplement for Ibrance (palbociclib), Pfizer, NDA212436 SUPPL-12. FDA letter.
Jun 24: the FDA approved an efficacy supplement for Ibrance (palbociclib), Pfizer, NDA207103 SUPPL-24. FDA letter.
Jun 24: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-187. FDA letter.
Jun 24: the FDA approved an efficacy supplement for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck Sharp Dohme, BLA761467 SUPPL-4. FDA letter.
Jun 24: the FDA approved an efficacy supplement for Trodelvy (sacituzumab govitecan), Immunomedics Inc, BLA761115 SUPPL-64. FDA letter.
Jun 24: the FDA approved an efficacy supplement for Trodelvy (sacituzumab govitecan), Immunomedics Inc, BLA761115 SUPPL-63. FDA letter.
Jun 24: the FDA approved an efficacy supplement for Tryngolza (olezarsen sodium), Ionis Pharms Inc, NDA218614 SUPPL-4. FDA letter.
Jun 25: the FDA approved an efficacy supplement for Xeomin (incobotulinumtoxina), Merz Pharms, BLA125360 SUPPL-108. FDA letter.
Jun 26: the FDA approved an efficacy supplement for Romvimza (vimseltinib), Deciphera Pharms, NDA219304 SUPPL-2. FDA letter.
Jun 26: the FDA approved an efficacy supplement for Skyrizi (risankizumab-rzaa), Abbvie Inc, BLA761105 SUPPL-45. FDA letter.
Jun 29: the FDA approved an efficacy supplement for Zoryve (roflumilast), Arcutis, NDA215985 SUPPL-15. 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. ← May 2026 · July 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026