FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease
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 ...