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 ...

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 ...

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

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 ...

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 ...

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 ...

The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease PR Newswire TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 ...