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 ...

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...

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

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

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 ...