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 ...

The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at up-to-date safety data on Leqembi (lecanemab) at its next meeting in ...

European Union's human medicines committee (CHMP) said on Friday it is not updating its opinion on Eisai and Biogen's ...

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 ...

Image Source: Zacks Investment Research We remind the investors that the CHMP had earlier given a negative opinion regarding marketing approval for Leqembi for early Alzheimer's disease in July 2024.

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 ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) ...

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 ...