Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...

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

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

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

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

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

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

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 ...

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 announced FDA approval for LEQEMBI’s once every four weeks maintenance dosing for Alzheimer’s disease treatment. Eisai Co., Ltd. and Biogen Inc. announced that the U.S. FDA ...

Jan 31 (Reuters) - The European medicines regulator said on Friday it will review safety information for Eisai (4523.T), opens new tab and Biogen's (BIIB.O), opens new tab Leqembi, nearly three ...

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 ...