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

Shares of BioArctic AB (STO:BIOA B) climbed 4.8% following the announcement of its partner Eisai's robust sales figures for ...

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 ...

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 ...

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 ...

The Washington University trial comes as part of a larger platform study which hopes to understand if Alzheimer's disease can ...

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 ...