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 ...

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

The review is conducted in response to a request from the European Commission, and may require the agency to update its ...

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 ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee ...

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 ...

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 ...

Despite the regulatory setback, BioArctic's partner Eisai has stated that the safety profile of lecanemab reported in clinical practice in the United States, Japan, and other countries is consistent ...

Eisai and Biogen have reported data showing that the benefit of treatment with their Alzheimer's disease therapy Leqembi appears to build over time, with no increase in safety risks. The results ...

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 ...