Rilzabrutinib PDUFA Date (Sanofi)
FDA PDUFA decision date for Rilzabrutinib is August 29, 2025. Developed by Sanofi. Indication: Immune thrombocytopenia (ITP). Current status: Approved.
Indication
Immune thrombocytopenia (ITP)
Regulatory details
- Company: Sanofi
- Therapeutic area: Immunology / Hematology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2025-08-29
- Outcome: Approved