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.

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

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 ...

EMA committee recommends approval of BeOne Medicines’ Tevimbra to treat neoadjuvant/adjuvant NSCLC: San Carlos, California Wednesday, July 30, 2025, 12:00 Hrs [IST] BeOne Medici ...

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 ...

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 ...

PTC Therapeutics Inc. will be launching its oral phenylketonuria therapy, Sephience (sepiapterin) in both the U.S. and Europe this summer, following the U.S. FDA approval just ahead of its July 29 ...

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion ...

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 ...

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 ...