News

The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25 ...
Eli Lilly (LLY) recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its Alzheimer's drug donanemab, underscoring the company's advancements in a ...
Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Gilead Sciences (NASDAQ:GILD) announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for ...
Pharmaceutical Technology on MSN1d

CHMP rejects Elevidys in latest setback for Sarepta

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...
The drug is administered subcutaneously twice a year, making it easier for high-risk patients to comply with prophylaxis.
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 ...
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 ...
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 ...
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 ...
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 ...