The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the monthly intravenous (IV) maintenance regimen of Leqembi ® (lecanemab-irmb ...
Eisai has filed to extend the label for its Alzheimer’s disease therapy Leqembi to include a maintenance ... that is specific to the subcutaneous form. In a statement, Eisai and Biogen said ...
The agency has set a Prescription Drug User Fee Act (PDUFA) action date for the weekly autoinjector form of Leqembi for 31 August 2025. Eisai and Biogen’s antibody is currently infused every two ...
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