Filsuvez, Topical Gel for EB Wounds, Under FDA Priority Review

Filsuvez, Topical Gel for EB Wounds, Under FDA Priority Review

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Filsuvez, Topical Gel for EB Wounds, Under FDA Priority Review

The U.S. Food and Drug Administration (FDA) will give priority review to Amryt Pharma’s application seeking approval of Filsuvez (Oleogel-S10), a topical gel to treat skin wounds in people epidermolysis bullosa (EB). A final decision by the agency is expected by Nov. 30, according to the announced Prescription Drug User Fee Act (PDUFA) action date. Priority review is given by the FDA to treatment candidates for serious conditions that show the potential for significant benefits over currently…

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