Biogen, Eisai and BLA
Biogen/Eisai announce FDA BLA acceptance for injectable Alzheimer’s drug
Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for an injectable formulation of their Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb).
FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application.
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...
Biogen CEO Chris Viehbacher targets subcutaneous Leqembi release for Alzheimers treatment Biogens Chris Viehbacher outlines ...
To date, Leqembi has been approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, GB, Mexico, and Macau, and ...
The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an ...
Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. FDA has accepted Eisai's Biologics License Application for lecanemab-irmb, marketed as LEQEMBI, which is designed for subcutaneous ...
Viehbacher, "Biogen") announced today that Eisai has initiated the rolling submission ... for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing ...
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