The FDA last month accepted the application for subcutaneous Leqembi for maintenance dosing, with a target action date of ...

The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

Investing.com -- Shares of BioArctic AB (STO:BIOA B) climbed 4.8% following the announcement of its partner Eisai's robust sales figures for Leqembi, which exceeded consensus estimates. The ...

It seems Eisai and Biogen have another hurdle to jump over in their bid to get EU approval for their Alzheimer's disease therapy Leqembi. In the latest development, the European Commission has ...

The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.

The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...

CHICAGO--The benefit of Eisai and Biogen’s Alzheimer’s drug Leqembi in patients with early-stage Alzheimer’s appears to increase with continued use with no new safety issues, according to ...

Last accessed: January 2025. 3 Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen. Last accessed: January 2025. 4 The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi ...

Eisai and Biogen have completed their rolling biologics license application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi previously delayed by the FDA on ...