Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

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

Eisai and Biogen update on lecanemab's EU regulatory review for early Alzheimer’s disease treatment following positive CHMP opinion. Eisai Co., Ltd. and Biogen Inc. have provided an update on ...

Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...

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 ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee ...

Biogen and Eisai have hit another bump in their quest ... said the European Commission has asked the Committee for Medicinal Products for Human Use to consider information on the safety of the ...

Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.

Biogen (BIIB) and Eisai announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as ...

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

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

In November 2024, the Committee for Medicinal Products for Human Use or CHMP had ... new safety signals have been identified. Biogen and Eisai remain confident that these requests can be addressed ...