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

In the latest of a string of issues Sarepta has faced, the CHMP said it was recommending against approval as the pivotal ...

Gilead Sciences (NASDAQ:GILD) announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for ...

Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a positive opinion on ...

The drug is administered subcutaneously twice a year, making it easier for high-risk patients to comply with prophylaxis.

Gilead on Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers lenacapavir for use as pre-exposure prophylaxis, or PrEP, to reduce ...

New York drugmaker Pfizer and Mainz, Germany, immunotherapy company BioNTech said the European Commission, which generally follows CHMP's advice, will now review the recommendation, with a final ...

TRYNGOLZA was approved in the United States in December 2024 and granted orphan designation in the EU. Olezarsen is also being evaluated for sHTG, a serious condition defined by dangerously high ...

STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- 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 ...

LONDON, Oct. 23, 2008-On 23 October 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing ...

Moderna, Inc., a biotechnology company pioneering messenger RNA therapeutics and vaccines, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has ...