The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...

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 ...

Leqembi is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option. The Prescription Drug User Fee ...

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 ...

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.

The integration of artificial intelligence (AI) in packaging manufacturing has become a necessity. AI is revolutionizing traditional processes, driving efficiency, and creating new opportunities for ...

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 ...