21 July 2025 - Approval is based on positive results from the pivotal Phase 3 ARANOTE trial and reinforces darolutamide’s established ...
21 July 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
18 July 2025 - Ezmekly is the first and only therapy to receive marketing authorisation in the EU for both adults ...
10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...
10 July 2025 - New indication based on results of RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival. ...
8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...
3 July 2025 - Biocon Biologics today announced that the European Commission has granted marketing authorisation in the European Union ...
1 July 2025 - Approximately 31,000 people with cystic fibrosis in the EU are now eligible for this new highly ...
4 July 2025 - Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk ...
1 July 2025 - Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial. ...
3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...
27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...
27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...
23 June 2025 - Launch to be initiated in Germany. ...
24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA ...