The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25 ...

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 ...

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

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

"Gilead wins positive European approval opinion for twice-yearly HIV injection" was originally created and published by ...

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 ...

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 ...

Gilead Sciences (NASDAQ:GILD) announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for lenacapavir to be ...

EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Marketing Authorization Of Moderna’s RSV Vaccine, mRESVIA (R) ACCESSWIRE Updated June 28, 2024 4:15 AM ...

BeiGene's Tevimbra gets a highly sought after recommendation. The oncology company said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive ...

The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease Provided by PR Newswire Feb 28, 2025 5:23am ...