As we enter the second half of 2025, it’s important to keep apprised of the upcoming FDA approval dates for new drugs. The decisions made on these dates will be key to understanding the industry’s trajectory during the remainder of the year.
Read on for an overview of the FDA’s upcoming decision dates for new drug approvals in the second quarter of 2025:
| PDUFA Date | COMPANY NAME | Orphan Drug | Indication | |
| 04-02-25 | Aldeyra Therapeutics, Inc. | Reproxalap | Dry eye disease | |
| 04-02-25 | Novartis | Vanrafia (atrasentan) | IgA nephropathy | |
| 04-03-25 | Exelixis, Inc. | CABOMETYX | Advanced neuroendocrine tumors | |
| 04-03-25 | Amgen Inc. | Uplizna | Immunoglobulin G4-related disease | |
| 04-10-25 | argenx SE | VYVGART SC pre-filled syringe | Generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy | |
| 04-21-25 | Bristol-Myers Squibb Co. | Nivolumab plus ipilimumab | Hepatocellular carcinoma (HCC) | |
| 04-26-25 | Telix Pharmaceuticals Limited | TLX101-CDx | imaging of glioma | |
| 04-29-25 | Abeona Therapeutics | Prademagene zamikeracel (pz-cel) | Recessive Dystrophic Epidermolysis Bullosa | |
| 04-29-25 | Stealth BioTherapeutics | Elamipretide | Barth syndrome | |
| 04-30-25 | Johnson & Johnson | Nipocalimab | Generalized myasthenia gravis | |
| 05-07-25 | GSK | Nucala | Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype | |
| 05-19-25 | Novavax Inc. | NVX-CoV2705 (Nuvaxovid) | COVID-19 vaccine for individuals aged 12 to 64 years with at least one underlying condition, such as asthma, cancer, diabetes, obesity, or smoking | |
| 05-22-25 | Arcutis Biotherapeutics Inc. | ZORYVE (roflumilast) | Scalp and body psoriasis in adults and adolescents ages 12 and over | |
| 05-24-25 | Liquidia Corporation | Yutrepia | Pulmonary arterial hypertension | |
| 05-26-25 | Merck | WELIREG (belzutifan) | Advanced Pheochromocytoma and Paraganglioma (PPGL) | |
| 05-28-25 | Eton Pharmaceuticals, Inc | ET-400 | Pediatric adrenal insufficiency | |
| 05-31-25 | Moderna | mRNA-1283 | Respiratory COVID-19 vaccine | |
| 06-10-25 | Merck | Clesrovimab | RSV Disease | |
| 06-12-25 | Moderna, Inc | mRNA-1345 | Respiratory syncytial virus (RSV) vaccine in high-risk adults aged 18-59 | |
| 06-13-25 | UroGen Pharma Ltd. | UGN-102 | Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer | |
| 06-17-25 | KalVista Pharmaceuticals, Inc. | Sebetralstat | Hereditary Angioedema | |
| 06-19-25 | Gilead Sciences Inc. | Lenacapavir | HIV prevention | |
| 06-20-25 | Sanofi & Regeneron | Dupixent | Bullous Pemphigoid | |
| 06-20-25 | GSK | Shingrix | Shingles (herpes zoster). | |
| 06-23-25 | Nuvation Bio | Taletrectinib | Advanced ROS1-positive non-small cell lung cancer | |
| 06-23-25 | Merck & Co Inc. | Keytruda (pembrolizumab) | Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma | |
| 06-28-25 | Unicycive Therapeutics, Inc. | Oxylanthanum Carbonate | Hyperphosphatemia in patients with Chronic Kidney Disease on Dialysis | |
| 06-30-25 | Verastem, Inc. | Avmapki Fakzynja Co-Pack | KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) |
