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 25 efficacy supplements (new uses for approved drugs) in June 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 15
Jun 5: the FDA approved Widaplik (telmisartan, amlodipine and indapamide), Azurity, NDA219423 ORIG-1 (Type 4 - New Combination). FDA letter.
Jun 5: the FDA approved Xifyrm (meloxicam), Azurity, NDA218395 ORIG-1. FDA letter.
Jun 9: the FDA approved Enflonsia (clesrovimab), Merck Sharp Dohme, BLA761432 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jun 9: the FDA approved Rocuronium (rocuronium bromide), Fresenius Kabi Usa, NDA217472 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Jun 10: the FDA approved Brukinsa (zanubrutinib), Beone Medicines Usa, NDA218785 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jun 10: the FDA approved Brukinsa (zanubrutinib), Beone Medicines Usa, NDA218785 ORIG-2 (Type 3 - New Dosage Form). FDA letter.
Jun 11: the FDA approved Ibtrozi (taletrectinib), Nuvation, NDA219713 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jun 12: the FDA approved Zusduri (mitomycin), Urogen Pharma, NDA215793 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jun 16: the FDA approved Andembry (garadacimab), Csl Behring Llc, BLA761367 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jun 16: the FDA approved Arynta (lisdexamfetamine dimesylate oral), Azurity, NDA219847 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Jun 16: the FDA approved Carbon Dioxide, Usp (carbon dioxide), General Distributing Company, NDA220634 ORIG-1. FDA letter.
Jun 18: the FDA approved Yeztugo (lenacapavir sodium), Gilead Sciences Inc, NDA220018 ORIG-1 (Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated). FDA letter.
Jun 18: the FDA approved Yeztugo (lenacapavir sodium), Gilead Sciences Inc, NDA220020 ORIG-1 (Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated). FDA letter.
Jun 23: the FDA approved Datroway (datopotamab deruxtecan-dlnk), Daiichi Sankyo Inc, BLA761464 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Jun 27: the FDA approved Avgemsi (gemcitabine), Avyxa Holdings, NDA219920 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
New uses for approved drugs (efficacy supplements) · 25
Jun 3: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-173. FDA letter.
Jun 3: the FDA approved an efficacy supplement for Nubeqa (darolutamide), Bayer Healthcare, NDA212099 SUPPL-8. FDA letter.
Jun 6: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-183. FDA letter.
Jun 6: the FDA approved an efficacy supplement for Vyloy (zolbetuximab), Astellas, BLA761365 SUPPL-3. FDA letter.
Jun 10: the FDA approved an efficacy supplement for Mavyret (glecaprevir and pibrentasvir), Abbvie, NDA215110 SUPPL-5. FDA letter.
Jun 10: the FDA approved an efficacy supplement for Mavyret (glecaprevir and pibrentasvir), Abbvie, NDA209394 SUPPL-19. FDA letter.
Jun 10: the FDA approved an efficacy supplement for Nityr (nitisinone), Cycle, NDA209449 SUPPL-18. FDA letter.
Jun 11: the FDA approved an efficacy supplement for Hectorol (doxercalciferol), Sanofi, NDA020862 SUPPL-33. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-180. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Talzenna (talazoparib), Pfizer, NDA217439 SUPPL-3. FDA letter.
Jun 12: the FDA approved an efficacy supplement for Talzenna (talazoparib), Pfizer, NDA211651 SUPPL-13. FDA letter.
Jun 18: the FDA approved an efficacy supplement for Dupixent (dupilumab), Regeneron Pharmaceuticals, BLA761055 SUPPL-70. FDA letter.
Jun 18: the FDA approved an efficacy supplement for Monjuvi (tafasitamab-cxix), Morphosys Us Inc, BLA761163 SUPPL-13. FDA letter.
Jun 18: the FDA approved an efficacy supplement for Zejula (niraparib), Glaxosmithkline, NDA214876 SUPPL-3. FDA letter.
Jun 20: the FDA approved an efficacy supplement for Benlysta (belimumab), Glaxosmithkline Llc, BLA761043 SUPPL-34. FDA letter.
Jun 20: the FDA approved an efficacy supplement for Descovy (emtricitabine and tenofovir alafenamide), Gilead Sciences Inc, NDA208215 SUPPL-25. FDA letter.
Jun 20: the FDA approved an efficacy supplement for Descovy (emtricitabine and tenofovir alafenamide), Gilead Sciences Inc, NDA208215 SUPPL-23. FDA letter.
Jun 20: the FDA approved an efficacy supplement for Tybost (cobicistat), Gilead Sciences Inc, NDA203094 SUPPL-17. FDA letter.
Jun 20: the FDA approved an efficacy supplement for Tybost (cobicistat), Gilead Sciences Inc, NDA203094 SUPPL-18. FDA letter.
Jun 23: the FDA approved an efficacy supplement for Amyvid (florbetapir f 18), Avid Radiopharms Inc, NDA202008 SUPPL-46. FDA letter.
Jun 23: the FDA approved an efficacy supplement for Neuraceq (florbetaben f 18), Lantheus, NDA204677 SUPPL-24. FDA letter.
Jun 23: the FDA approved an efficacy supplement for Vizamyl (flutemetamol f-18), Ge Healthcare, NDA203137 SUPPL-24. FDA letter.
Jun 27: the FDA approved an efficacy supplement for Gamifant (emapalumab-lzsg), Novimmune S.A., BLA761107 SUPPL-18. FDA letter.
Jun 27: the FDA approved an efficacy supplement for Levetiracetam, Aprecia Pharms, NDA207958 SUPPL-27. FDA letter.
Jun 27: the FDA approved an efficacy supplement for Tyzavan (vancomycin), Hikma, NDA211962 SUPPL-17. 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 2025 · July 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025