Dupixent (dupilumab) PDUFA Date (Sanofi / Regeneron)
FDA PDUFA decision date for Dupixent (dupilumab) is April 27, 2026. Developed by Sanofi / Regeneron. Indication: Chronic spontaneous urticaria (CSU) in children. Current status: Approved.
Indication
Chronic spontaneous urticaria (CSU) in children
Regulatory details
- Company: Sanofi / Regeneron
- Therapeutic area: Immunology / Dermatology
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2026-04-27
- Outcome: Approved