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.
Biogen, Eisai say injectable Alzheimer’s therapy granted FDA review
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) announced that the U.S. Food and Drug Administration (FDA) accepted a marketing application for an injectable version of their Alzheimer’s therapy lecanemab.
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
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) for weekly maintenance dosing.
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/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
BioArctic announces US FDA accepts Eisai’s BLA for subcutaneous maintenance dosing of Leqembi
BioArctic announces US FDA accepts Eisai’s BLA for subcutaneous maintenance dosing of Leqembi: Stockholm Wednesday, January 15, 2025, 13:00 Hrs [IST] BioArctic AB (publ) announc
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Eisai Co., Ltd. (ESAIY)
Eisai Inc. announced today that screening for Study E2086-A001-101 (Study 101) to assess the efficacy, safety and tolerability of E2086, a novel selective orexin-2 receptor, is now registered on ...
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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 ...
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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 ...
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 ...
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Could New Leqembi Formulations Boost Lagging Sales in Alzheimer’s?
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 ...
Alzheimers Drugs Market Projected To Reach USD 12.26 Bn by 2032 | Key Players Amgen Inc, AstraZeneca, Eisai Co.Ltd.
Laura Bolognesi is leading the B2AlzD2 Joint Lab at UNIBO, with Brazilian universities to develop Alzheimer's drugs from ...