FDA accepts Eisai’s sBLA for intravenous LEQEMBI to treat early Alzheimer’s
A decision on the approval under the Prescription Drug User Fee Act (PDUFA) is anticipated on 25 January 2025. LEQEMBI is intended to treat AD patients having mild
The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).