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

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 ...

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

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 ...

Eisai and Biogen update on lecanemab's EU regulatory ... In November 2024, the Committee for Medicinal Products for Human Use recommended approval for lecanemab, which is indicated for early ...

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

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

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

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 ...

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

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 ...