FDA Accepts Priority Review for Sanofi and Regeneron’s Dupixent in Allergic Fungal Rhinosinusitis
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Sanofi and Regeneron announced that the FDA has accepted their supplemental biologics license application for Dupixent in treating allergic fungal rhinosinusitis. This application is based on positive Phase 3 study results. The FDA's target action date is February 28, 2026. If approved, Dupixent will be the first medicine specifically indicated for this condition, marking its ninth FDA-approved indication.
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