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

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

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

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

The global health landscape faces challenges and innovations, with the European review of Alzheimer's drug Leqembi, Ebola ...

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

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two ...

With thousands of press releases published each week, it can be difficult to keep up with everything on . To help healthcare ...

Financial writer recommends Voyager Therapeutics, Inc. for high-risk investors due to promising preclinical Alzheimer'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 ...

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 ...