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

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

The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...

The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...

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

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...

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 ...

The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.

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 ...

Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing ...

Biogen and Eisai have hit another bump in their quest to win European regulatory approval of their Alzheimer's drug Leqembi. The companies on Friday said the European Commission has asked the ...