Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products ...

The drug failed to meet its primary endpoints in clinical trials, but subgroup analyses hinted at modest benefits.

IntraBio Inc., a biopharmaceutical company focused on developing therapies for rare neurological diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products ...

The opinion is based on positive data from the phase 3 Balance study, which showed a significant reduction of triglycerides ...

Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

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 ...

EMA committee recommends marketing approval for Biogen’s Zurzuvae to treat women with postpartum depression: Cambridge, Massachusetts Monday, July 28, 2025, 17:00 Hrs [IST] Biog ...

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 CHMP’s recommendation for ZURZUVAE will now be reviewed by the EC for marketing authorization in the European Union with a final decision expected in the third quarter of 2025. The U.S. FDA ...

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

Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.