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

The drug targets the overgrowth of synovial cells and inflammatory components that drive tumor development and joint ...

Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on discovering, developing, and commercializing important ...

Moderna has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use ...

"Tevimbra is already approved in the EU across multiple settings in [non-small cell lung cancer], the most common form of lung cancer, and this positive CHMP opinion expands its potential to help ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy: Basel Monday, July 28, 2025, 15:00 Hrs [I ...

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 ...

Investing.com -- BeOne Medicines AG (NASDAQ: ONC) stock gained 2.5% in pre-market trading after the company announced a positive recommendation from the European Medicines Agency for its cancer drug ...

Recommendation based on Phase 3 RATIONALE-315 study, in which TEVIMBRA demonstrated clinically meaningful and statistically significant improvement in event-free survival and major pathological respon ...

Sarepta Therapeutics (SRPT) shares dropped sharply on Monday following news that the FDA is investigating a patient death potentially connected to its gene therapy, Elevidys.