The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25 ...

--BioArctic AB's partner Eisai today announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ ...

Moderna (MRNA) nnounced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for an updated ...

The opinion is based on positive data from the phase 3 Balance study, which showed a significant reduction of triglycerides ...

Gilead Sciences (NASDAQ:GILD) announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for lenacapavir to be ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...

The CHMP’s recommendation for ZURZUVAE will now be reviewed by the EC for marketing authorization in the European Union with a final decision expected in the third quarter of 2025. The U.S. FDA ...

Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Marketing Authorization Of Moderna’s RSV Vaccine, mRESVIA (R) ACCESSWIRE Updated June 28, 2024 4:15 AM ...

The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU Provided by PR Newswire Feb 28, 2025 5:11am ...

TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025/ PRNewswire/-- Eisai Co., Ltd. and Biogen Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency ...