FiercePharma19h
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 ...
pharmaphorum2d
EMA experts will look again at Leqembi's safety data
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 ...
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 ...
Medscape29d
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 ...
Benzinga.com17d
What To Expect From Alzheimer's Drugmaker Biogen's Q4 Earnings On Wednesday?
Leqembi is indicated for Alzheimer's disease ... The European Commission asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP ...
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) ...