EMA

NEWS DESK

More efficacious dose of Wegovy® recommended by the European Medicines Agency can help people with obesity achieve an average of 20.7% weight loss

News Desk 19/12/2025

Today, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a higher dose of Wegovy® (semaglutide 7.2 mg), bringing it a step closer to offering individuals with obesity in the EU a new Wegovy® option for even greater weight

NEWS DESK

BeOne Medicines Receives PRIME Designation from the European Medicines Agency for BGB-16673 in Waldenstrom’s Macroglobulinemia

PR News Desk 31/07/2025

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to the Company’s investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously

NEWS DESK

EU Notified Body (BSI Netherlands) and the EMA Grant Approval of the LeukoStrat® CDx FLT3 Mutation Assay

PR News Desk 08/10/2024

Invivoscribe is excited to announce that their CE-2797 IVD certified LeukoStrat® CDx FLT3 Mutation Assayhas been approved by BSI (Netherlands) and the EMA to aid in the selection of individuals in the European Union and European Economic Area with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment

NEWS DESK

Takeda Receives Positive CHMP Opinion for Recombinant ADAMTS13

News Desk 01/06/2024

Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP. The European Commission (EC) will consider the CHMP