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 ...

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

Biogen Inc. (NASDAQ:BIIB)’s commercial strategies are expected to enhance the uptake of Leqembi. Furthermore, the company continues to focus on its pipeline, with expected regulatory filings ...

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 ...

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

Biogen Inc. (NASDAQ:BIIB)’s commercial strategies are expected to enhance the uptake of Leqembi. Furthermore, the company continues to focus on its pipeline, with expected regulatory filings ...

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 ...

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to ...