Upcoming FDA action dates under the Prescription Drug User Fee Act (PDUFA). These dates represent the FDA's commitment to complete review of New Drug Applications (NDAs) and Biologics License Applications (BLAs).
| Drug | Company | Indication | PDUFA Date |
|---|---|---|---|
| Fitusiran | Sanofi | Hemophilia A and B | March 28, 2026 |
| Amvuttra | Alnylam | ATTR-CM | March 23, 2026 |
| Reproxalap | Aldeyra Therapeutics | Dry Eye Disease | March 16, 2026 |
| Deucravacitinib (Sotyktu) | Bristol Myers Squibb | Psoriatic Arthritis | March 6, 2026 |
| Dupixent | Sanofi/Regeneron | Allergic Fungal Rhinosinusitis | February 28, 2026 |
| Anaphylm (Epinephrine) | Aquestive Therapeutics | Type 1 Allergic Reactions | January 31, 2026 |
| Filspari (Sparsentan) | Travere Therapeutics | Focal Segmental Glomerulosclerosis | January 13, 2026 |
| Tabelecleucel | Atara Biotherapeutics | EBV+ Post-Transplant Lymphoproliferative Disease | January 10, 2026 |
The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 to provide the FDA with resources to expedite drug review. Under PDUFA, the FDA commits to specific review timelines:
Priority Review is for drugs treating serious conditions with significant advantages over existing therapies. Standard Review applies to all other applications.
PDUFA dates are not approval deadlines—the FDA may approve drugs earlier or request additional information. However, these dates provide important milestones for investors and industry analysts tracking the regulatory review process.
Note: PDUFA dates are subject to change based on FDA review timelines and sponsor submissions. Check the FDA website for official approval announcements.