Rusfertide PDUFA Date (Takeda)
FDA PDUFA decision date for Rusfertide is September 15, 2026. Developed by Takeda. Indication: Polycythemia vera. Current status: Approved.
Indication
Polycythemia vera
Notes
Hepcidin mimetic. Q3 2026 PDUFA — exact date TBD.
Regulatory details
- Company: Takeda
- Therapeutic area: Rare Disease / Hematology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-09-15
- Outcome: Approved