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

The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly ...

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 ...

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 ...

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 ...

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 ...

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 ...

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