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 ...

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

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

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

Recent health news highlights include a review of the safety of Alzheimer's drug Leqembi, legal charges against a New York ...

Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) are expected to face another delay in launching their new Alzheimer's drug, lecanemab, in the EU after the European Commission on Friday asked the region's ...

With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.