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 ...

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

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 ...

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 ...

It was a busy week for the biotech sector as the fourth-quarter earnings season kicked in. While Regeneron REGN gained following the announcement, Amgen AMGN was in the red. Meanwhile, other pipeline ...

Children who inherit genetic mutations from parents with early-onset Alzheimer’s typically show signs of dementia at the same ...

An international clinical trial aimed at preventing Alzheimer’s disease (AD) in young adults who are at risk of developing ...