FiercePharma9h
CHMP again backs Leqembi amid flurry of approval recommendations
Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...
The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
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 ...
pharmaphorum4d
CHMP calls in advisors to assist in Leqembi review
Leqembi (lecanemab), which targets the amyloid ... scientific and technical matters for products being reviewed by the CHMP and are called in at the discretion of the regulator; for example ...
MarketWatch28d
Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
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 ...
Hosted on MSN25d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
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 ...
Medscape28d
EMA to Review New Safety Data on Alzheimer’s Drug Leqembi
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: The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) ...