As Q4 2025 approaches its final stretch, several upcoming PDUFA dates could mark important regulatory milestones across biotech and biopharma. These FDA decisions may influence clinical strategy, hiring plans, and broader market momentum as companies head into the new year.
| PDUFA Date | COMPANY NAME | Orphan Drug | Indication | |
| 10-7-2025 | Boehringer Ingelheim | Jascayd (nerandomilast) | Idiopathic Pulmonary Fibrosis | |
| 10-7-2025 | Jazz Pharmaceuticals | Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) | Extensive-Stage Small-Cell Lung Cancer | |
| 10-7-2025 | Regeneron Pharmaceuticals | Libtayo (cemiplimab-rwlc) | High-risk cutaneous squamous cell carcinoma | |
| 10-19-2025 | AstraZeneca and Amgen | Tezspire (tezepelumab) | Chronic Rhinosinusitis With Nasal Polyps | |
| 10-19-2025 | Roche | Gazyva/Gazyvaro (obinutuzumab) | Lupus nephritis | |
| 10-20-2025 | Glaukos | Epioxa | Keratoconus | |
| 10-23-2025 | GSK | Blenrep combinations | Multiple myeloma | |
| 10-24-2025 | Bayer | Elinzanetant | Moderate-to-severe vasomotor symptoms (VMS) associated with menopause | |
| 10-25-2025 | Merck | Winrevair (sotatercept-csrk) | Pulmonary arterial hypertension | |
| 10-25-2025 | Syndax Pharma | Revuforj | Relapsed or refractory mutant NPM1 acute myeloid leukemia | |
| 11-18-2025 | Arrowhead Pharmaceuticals | Plozasiran | Familial chylomicronemia syndrome | |
| 11-25-2025 | AstraZeneca | Durvalumab (IMFINZI) | Resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers | |
| 11-28-2025 | Bayer | Sevabertinib | Non-small cell lung cancer harboring HER2 activating mutations | |
| 11-28-2025 | Otsuka Holdings | Sibeprenlimab | Immunoglobulin A Nephropathy (IgAN) in adults | |
| 11-30-2025 | Ascendis Pharma | TransCon CNP | Children with achondroplasia | |
| 11-30-2025 | Kura Oncology | Ziftomenib | Relapsed or refractory acute myeloid leukemia with a nucleophosmin 1 mutation | |
| 12-5-2025 | Bristol Myers Squibb | Breyanzi | Relapsed or refractory marginal zone lymphoma | |
| 12-5-2025 | AxoGen | Avance Nerve Graft | Surgical repair of severed peripheral nerves | |
| 12-7-2025 | Agios Pharmaceuticals | Pyrukynd | Adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia | |
| 12-11-2025 | GSK | Blujepa | Uncomplicated urogenital gonorrhoea in patients 12 years of age and older. | |
| 12-11-2025 | Amgen | Uplizna | Generalized myasthenia gravis | |
| 12-12-2025 | Biocryst Pharmaceuticals | ORLADEYO (berotralstat) | Hereditary angioedema (HAE) aged 2 to 11 years | |
| 12-13-2025 | Milestone Pharmaceuticals | CARDAMYST (etripamil) | Paroxysmal supraventricular tachycardia | |
| 12-15-2025 | Innoviva | Zoliflodacin | Uncomplicated gonorrhea in adults and pediatric patients 12 years and older | |
| 12-16-2025 | GSK | Depemokimab | Asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation | |
| 12-26-2025 | Omeros Corp. | Narsoplimab | Hematopoietic stem cell transplant-associated thrombotic microangiopathy | |
| 12-26-2025 | Cytokinetics | Aficamten | Obstructive hypertrophic cardiomyopathy | |
| 12-28-2025 | Sanofi | Tolebrutinib | Non-relapsing secondary progressive multiple sclerosis | |
| 12-30-2025 | Vanda Pharmaceuticals | Tradipitant | Motion sickness | |
| 12-30-2025 | Corcept Therapeutics | Relacorilant | Endogenous hypercortisolism | |
| Q4 2025 | Amneal Pharmaceuticals, Inc. | Denosumab biosimilar to XGEVA | Bone Cancer | |
| Q4 2025 | Biohaven Ltd. | Troriluzole | Spinocerebellar Ataxia | |
| Q4 2025 | Regeneron Pharmaceuticals Inc | EYLEA HD | Macular edema |
