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

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 ...

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

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 ...

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

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Sobi® today announced that the Committee for Medicinal Products for Human Use ...

The review for IOA began on 23 December 2009 with an active review time of 210 days.The Committee gave also a positive opinion for Cinryze (C1 inhibitor, human), an orphan medicine from ViroPharma ...

Gilead receives positive CHMP opinions under accelerated review from EMA for twice-yearly lenacapavir for HIV prevention: Foster City, California Saturday, July 26, 2025, 13:00 Hr ...

EMA's CHMP backs key drugs from KalVista, Biogen & Ionis for conditions like hereditary angioedema & postpartum depression.

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 ...

The Committee adopted positive opinions recommending the granting of marketing authorisations for the following new medicines: Eliquis (apixaban), from Bristol-Myers Squibb/Pfizer EEIG, intended ...