Dupixent (dupilumab) PDUFA Date (Sanofi / Regeneron)

Name: FDA PDUFA Decision: Dupixent (dupilumab)
Start: 2026-02-28

FDA PDUFA decision date for Dupixent (dupilumab) is February 28, 2026. Developed by Sanofi / Regeneron. Indication: Allergic fungal rhinosinusitis (AFRS). Current status: Approved.

Indication

Allergic fungal rhinosinusitis (AFRS)

Regulatory details

Company: Sanofi / Regeneron
Therapeutic area: ENT / Immunology
Application type: sBLA
Review type: Priority
PDUFA date: 2026-02-28
Outcome: Approved

Dupixent (dupilumab) PDUFA Date — Sanofi / Regeneron