In a transformative year like 2025, the FDA’s upcoming approval decisions could influence the biotech landscape and signal key trends for 2026.
See what’s on the horizon for new drug approvals in the remainder of 2025.
| PDUFA Date | COMPANY NAME | Orphan Drug | Indication | |
| 7-10-25 | Regeneron Pharmaceuticals | Linvoseltamab | Relapsed/Refractory Multiple Myeloma | |
| 7-22-25 | Replimune | RP1 (vusolimogene oderparepvec) | Advanced melanoma | |
| 7-24-25 | Sobi North America | Avatrombopag | Immune thrombocytopenia | |
| 7-27-25 | Ascendis Pharma & Royalty Pharma | Skytrofa | Growth hormone deficiency | |
| 7-28-25 | Apellis Pharmaceuticals | Empaveli (pegcetacoplan) | C3G and primary IC-MPGN | |
| 7-29-25 | PTC Therapeutics | Sepiapterin | Phenylketonuria (PKU) | |
| 7-30-25 | Regeneron Pharmaceuticals | Odronextamab | Follicular lymphoma | |
| 7-31-25 | Novo Nordisk | Alhemo (concizumab) | Hemophilia A or B without inhibitors | |
| 8-6-25 | Jazz Pharmaceuticals | Dordaviprone (Modeyso) | H3 K27M-mutant diffuse midline glioma | |
| 8-8-25 | LENZ Therapeutics | LNZ100 | Presbyopia | |
| 8-9-25 | PharmaTher | Ketamine | Anesthesia, sedation, pain, mental health, and neurological indications | |
| 8-12-25 | Insmed | Brensocatib | Bronchiectasis | |
| 8-15-25 | Tonix Pharmaceuticals | TNX-102 SL | Fibromyalgia | |
| 8-18-25 | Ultragenyx & Abeona Therapeutics | UX111 | Treat Sanfilippo Syndrome Type A (MPS IIIA) | |
| 8-19-25 | Regeneron Pharmaceuticals & Bayer | EYLEA HD® (aflibercept) Injection 8 mg | Macular Edema Following Retinal Vein Occlusion (RVO) | |
| 8-19-25 | PTC Therapeutics | Vatiquinone | Friedreich’s ataxia | |
| 8-21-25 | Ionis Pharmaceuticals & Theratechnologies | Donidalorsen | Hereditary Angioedema | |
| 8-27-25 | Precigen | PRGN-2012 (zopapogene imadenovec) | Recurrent Respiratory Papillomatosis (RRP) | |
| 8-27-25 | Outlook Therapeutics | ONS-5010 | Wet age-related macular degeneration | |
| 8-28-25 | Travere Therapeutics | Filspari | Immunoglobulin A nephropathy (IgAN) | |
| 8-29-25 | Sanofi | Rilzabrutinib | Immune thrombocytopenia (ITP) | |
| 8-31-25 | Capricor Therapeutics | Deramiocel | Duchenne muscular dystrophy | |
| 8-31-25 | Biogen & Elsai | LEQEMBI subcutaneous autoinjector | early Alzheimer’s | |
| 9-12-25 | BioCryst Pharmaceuticals | Orladeyo (berotralstat) | Hereditary Angioedema (HAE) | |
| 9-19-25 | Incyte Corporation | Ruxolitinib cream | Atopic Dermatitis in pediatric patients | |
| 9-22-25 | Scholar Rock | Apitegromab | Spinal muscular atrophy | |
| 9-22-25 | Biogen | SPINRAZA | Spinal muscular atrophy | |
| 9-23-25 | Merck & Co Inc. | Subcutaneous Keytruda | Non-small cell lung cancer (NSCLC) | |
| 9-25-25 | Omeros Corp. | Narsoplimab | Hematopoietic stem cell transplant-associated thrombotic microangiopathy | |
| 9-25-25 | Crinetics Pharmaceuticals | Paltusotine | Acromegaly | |
| 9-28-25 | Sanofi | Tolebrutinib | Multiple sclerosis | |
| 9-30-25 | Fortress Biotech and Cyprium Therapeutics | CUTX-101 (Copper Histidinate) | Menkes disease |
