FDA, Biogen

Eisai and Biogen’s subcutaneous Leqembi set for FDA review
Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration (FDA) accepted a biologics licence application (BLA) for a subcutaneous version of the drug.
FDA accepts Eisai/Biogen’s BLA for LEQEMBI in early AD treatment
Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has accepted Eisai’s Biologics License Application, BLA, for
FDA sets August date for subcutaneous Leqembi decision
To date, Leqembi has been approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, GB, Mexico, and Macau, and in November was backed for approval in the EU, reversing an earlier negative decision.
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 Accepts Eisai And Biogen's BLA For Subcutaneous LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has accepted Eisai's Biologics
Biogen, Eisai say injectable Alzheimer’s therapy granted FDA review
Biogen (BIIB) and Eisai's (ESALF) (ESAIY) announce that U.S. FDA agreed to review their subcutaneous form of Alzheimer's therapy Leqembi. Read more here.
FiercePharma12h
Analysts tip Eisai, Biogen and Lilly to drive eightfold explosion in Alzheimer's market value
GlobalData analysts are predicting an Alzheimer’s disease market boom, tipping its value across major regions to increase ...
Benzinga.com3d
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application.
Healio2d
FDA grants biologics license application for monthly IV Leqembi
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...