The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

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

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

We recently compiled a list of the 12 Best Healthcare Stocks to Buy According to Analysts. In this article, we are going to ...

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 ...

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 ...

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), a leading biopharmaceutical company specializing in neurology and rare diseases, finds itself at a critical juncture as it navigates a complex landscape of opportunities and ...