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

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 ...

Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License ...

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

Eisai Co., Ltd. and Biogen Inc. have provided an update on the regulatory review of their Alzheimer’s disease treatment, lecanemab, in the European Union. In November 2024, the Committee for ...

“Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today an update on the ongoing regulatory ...

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

Since its approval in 2023, the Alzheimer's disease drug made by Biogen Inc. and Eisai Inc. has seen a lackluster launch. However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “n ...

Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. FDA has accepted Eisai's Biologics License Application for lecanemab-irmb, marketed as LEQEMBI, which is designed for subcutaneous ...

"Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today an update on the ongoing regulatory review of ...

On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI ...