Q3 2024 Management View 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 ...

The FDA last month accepted the application for subcutaneous Leqembi for maintenance dosing, with a target action date of ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the therapy for approval in ...

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

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 ...

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 ...

Biogen and Eisai have won Food and Drug Administration ... from the European Medicines Agency's Committee for Medicinal Products for Human Use after a re-examination of an earlier negative stance.

European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for ...

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

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 ...

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 ...