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Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer's disease
The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25 ...
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Positive CHMP Opinion for Gilead’s Lenacapavir in HIV Prevention
Gilead Sciences (NASDAQ:GILD) announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for ...
Eli Lilly (LLY) Gains CHMP Approval for Donanemab in Alzheimer's Treatment
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 ...
ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression
Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
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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 ...
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The Committee for Medicinal Products for Human Use (CHMP ... - Nasdaq
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 ...
Gilead Gets CHMP Backing for Twice-Yearly Treatment to Prevent HIV
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 ...
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Committee For Medicinal Products For Human Use Post-Authorisation ...
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 ...
Pfizer, BioNTech Get CHMP Backing for Updated Covid-19 Vaccine
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® (olezarsen) recommended for approval in the EU by CHMP for familial chylomicronemia syndrome (FCS)
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 ...
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The Committee for Medicinal Products for Human Use (CHMP) Reaffirms ...
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 ...
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The Committee for Medicinal Products for Human Use (CHMP) reaffirms ...
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 ...