FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application. Leqembi's subcutaneous dosing allows Alzheimer's patients to administer weekly ...
The European Medicines Agency (EMA) announced it will review new safety data on the Alzheimer’s disease drug Leqembi (lecanemab). This follows a prior decision to recommend its use in the ...
Biogen and Eisai have hit another bump in their quest to win European regulatory approval of their Alzheimer's drug Leqembi. The companies on Friday said the European Commission has asked the ...
LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease. A Prescription Drug User Fee Act (PDUFA ...
On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI ...
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