The European Medicines Agency has begun a review of medicines to treat alcohol dependency that contain sodium oxybate, it ...

Novo Nordisk said on Monday the European drugs regulator will allow a label update for its diabetes drug Ozempic to include a ...

Canalevia® (crofelemer delayed-release tablets), under the name Canalevia-CA1, is conditionally approved by the FDA for ...

Before this, Kriz, a trained veterinary surgeon, spent more than 16 years at the European Medicines Agency, where he also worked in risk assessments. In academia, he worked as a lecturer on equine ...

Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to the ...

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 ...

Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab for the treatment of hemat ...

The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant. About Hematopoietic stem cell transplant-associated thrombotic ...

Omeros Corporation has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for ...

European CE mark approval of the entire FemBloc® system marks pivotal achievement in expanding safe, accessible and ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee ...

Alvotech is also developing AVT29, a proposed biosimilar to Eylea® HD, a higher dose (aflibercept 8 mg) aflibercept. Advanz has licensed the distribution rights from Alvotech for both biosimilar ...