FDA Accepts sBLA for Priority Review of Dupilumab for CRSwNP in Adolescents
The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent, Regeneron Pharmaceuticals & Sanofi) for Priority Review as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The target action date for the FDA decision is […]