As we settle into 2025, staying informed about the latest developments in the ever-evolving biotech industry remains crucial. With the shifts and approvals that shaped 2024, the early months of this year will set the stage for emerging trends and key advancements in the sector.
Read on for an overview of the FDA’s upcoming decision dates for new drug approvals in Q1 2025 and how they may impact the industry moving forward.
| PDUFA Date | COMPANY NAME | Orphan Drug | Indication |
| 01-02-25 | Vertex Pharmaceuticals Inc. | Vanza triple | Cystic Fibrosis |
| 01-03-25 | OWP Pharmaceuticals | SUBVENITE (lamotrigine) | Epilepsy and bipolar disorder |
| 01-07-25 | Mesoblast Limited | Ryoncil (remestemcel) | Steroid-refractory acute graft versus host disease (SR-aGVHD) |
| 01-15-25 | Atara Biotherapeutics | Tabelecleucel (Tab-cel) | Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease |
| 01-17-25 | AstraZeneca & Daiichi Sankyo | Datopotamab Deruxtecan | Unresectable or metastatic hormone receptor positive, HER2-negative breast cancer |
| 01-17-25 | Amgen | Sotorasib (Lumakras) | Chemorefractory metastatic colorectal cancer (CRC) with a KRAS G12C mutation. |
| 01-25-25 | Eisai & Biogen | Leqembi | Early Alzheimer’s disease |
| 01-30-25 | Vertex Pharmaceuticals Inc. | JOURNAVX (suzetrigine) | Moderate-to-Severe Acute Pain |
| 01-30-25 | Axsome Therapeutics, Inc. | AXS-07 | Acute Treatment of Migraine |
| 02-01-25 | Supernus Pharmaceuticals, Inc. | SPN-830 | Motor fluctuations in Parkinson’s disease |
| 02-04-25 | Merus | Zenocutuzumab (Zeno) | NRG1+ NSCLC and Pancreatic Cancer |
| 02-07-25 | Indivior | Sublocade | Moderate to severe opioid use disorder (OUD) |
| 02-08-25 | Otsuka and Lundbeck | Brexpiprazole | Adults with post-traumatic stress disorder (PTSD) |
| 02-12-25 | Astellas Pharma Inc. | Izervay | Geographic atrophy secondary to age-related macular degeneration |
| 02-14-25 | GSK | 5-in-1 meningococcal ABCWY (MenABCWY) | Invasive meningococcal disease |
| 02-17-25 | Deciphera Pharmaceuticals | Vimseltinib | Tenosynovial giant cell tumor (TGCT) |
| 02-28-25 | Eton Pharmaceuticals | ET-400 | Adrenocortical Insufficiency |
| 02-28-25 | Springworks Therapeutics | Mirdametinib | Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) |
| 03-06-25 | scPharmaceuticals | Furosemide (Furoscix) | Edema due to fluid overload in patients with chronic kidney disease (CKD) |
| 03-06-25 | ARS Pharmaceuticals | Neffy | Type I allergic reactions, incl. anaphylaxis, in adults and children who weigh 15 to 30 kg |
| 03-12-25 | Organon & Co. | VTAMA (tapinarof) | Atopic dermatitis in adults and children two years of age and older |
| 03-18-25 | Neurotech Pharmaceuticals | NT-501 | Macular Telangiectasia Type 2 (MacTel) |
| 03-20-25 | Relay Therapeutics, Inc. | Lirafugratinib | Advanced or metastatic hepatocellular carcinoma |
| 03-20-25 | Elevar Therapeutics | Rivoceranib/Camrelizumab | Unresectable or metastatic hepatocellular carcinoma |
| 03-23-25 | Alnylam Pharmaceuticals | Vutrisiran | ATTR amyloidosis with cardiomyopathy (ATTR-CM) |
| 03-24-25 | Telix Pharmaceuticals Limited | TLX007-CDx | Prostate cancer |
| 03-25-25 | Theratechnologies Inc. | Tesamorelin F8 | Excess abdominal fat in adults with HIV and lipodystrophy |
| 03-26-25 | GSK | Gepotidacin | Urinary tract infections in female adults and adolescents |
| 03-27-25 | Soleno Therapeutics | Diazoxide choline (DCCR) | Prader-Willi syndrome |
| 03-27-25 | Milestone Pharmaceuticals | CARDAMYST (etripamil) | Paroxysmal supraventricular tachycardia (PSVT) |
| 03-28-25 | Sanofi & Alnylam Pharmaceuticals | Fitusiran | Hemophilia A or B |
| 03-28-25 | Mirum Pharmaceuticals Inc. | Chenodiol | Cerebrotendinous xanthomatosis |
| Q1 2025 | AstraZeneca & Daiichi Sankyo | Enhertu | HER2-low or HER2-ultralow metastatic breast cancer |
