BioArctic AB (publ) announced that the US Food and Drug Administration (FDA) has accepted BioArctic’s partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) ...

However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025. Since its approval in 2023, the launch of the ...

Jan 15, 2025 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for ...

Biogen Hits Lowest Stock Price Since 2013 as Leqembi Uptake Lags Biogen CEO Chris Viehbacher at JPM25 said that the pharma remains fully committed to the Alzheimer’s disease space and its therapeutic ...

Two years ago, Biogen and partner Eisai secured accelerated FDA approval for their Alzheimer’s med Leqembi, followed by a full approval in 2023. Since then, the companies have been gradually ...

STOCKHOLM, Jan. 14, 2025 /PRNewswire/ --BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's ...

The company's future hinges on the success of key products like Leqembi for Alzheimer's disease and Skyclarys for Friedreich's ataxia, while grappling with an underdeveloped pipeline and a ...

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 ...

Acceptance of the Biologics License Application for subcutaneous Leqembi is based on results from the Clarity AD open-label extension and modeling of observed data in patients with Alzheimer disease.

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 ...

Image credit: Shutterstock/ AtlasStudio. 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 ...

If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025. The FDA has accepted a biologics ...