Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has ...

The CHMP last July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look, and the CHMP in November reversed course ...

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 November 2024, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing granting a marketing authorization for Leqembi. This overturned its initial rejection in ...

The European review saga of Eisai and Biogen’s Alzheimer’s disease med Leqembi also got a CHMP update, with the agency agreeing to consider the European Commission’s request to consider ...