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

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

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

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

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 ...

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 ...

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

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 ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the ...

KalVista on Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers Ekterly in people ages 12 and older for the symptomatic treatment of ...

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

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 ...