Dupixent (dupilumab) PDUFA Date (Sanofi / Regeneron)
FDA PDUFA decision date for Dupixent (dupilumab) is June 23, 2025. Developed by Sanofi / Regeneron. Indication: Bullous pemphigoid. Current status: Approved.
Indication
Bullous pemphigoid
Regulatory details
- Company: Sanofi / Regeneron
- Therapeutic area: Dermatology / Immunology
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2025-06-23
- Outcome: Approved