Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with
06.03.2023 - Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with a Prescription Drug User Fee Act .