CEO Haruo Naito highlighted a 9% year-on-year revenue increase to 601.2 billion yen, with a focus on the pharmaceutical business driving growth. Key contributors included LEQEMBI with a 28.1 billion ...

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 ...

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 ...

STOCKHOLM, Jan. 31, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...

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 ...

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

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

With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.

The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...