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The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25 ...
Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Pharmaceutical Technology on MSN20h

CHMP rejects Elevidys in latest setback for Sarepta

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