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FDA Accepts Sanofi and Regeneron’s Dupixent sBLA for Priority Review
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and children aged 6 years and older with allergic fungal rhinosinusitis (“AFRS”), with a target action date of February 28, 2026….
By: Goodwin