3 July 2025 - Biocon Biologics today announced that the European Commission has granted marketing authorisation in the European Union ...
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 ...
2 July 2025 - Apotex today announced that Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, indicated for ...
2 July 2025 - Today, the FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal) for adult patients with locally advanced ...
2 July 2025 - Merck today announced that the US FDA has accepted and granted priority review for a new supplemental ...
2 July 2025 - Today the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals), a bispecific B-cell maturation antigen ...
30 June 2025 - No other concerns stated, including pre-clinical, clinical, or safety data. ...
27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...
27 June 2025 - Biocon Biologics is pleased to announce that Health Canada has granted a Notice of Compliance for Yesafili ...
27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...
28 June 2025 - Approval based on the pooled analysis of our pivotal EMERALD and NI-0501-06 studies, showing 54% of ...
23 June 2025 - Launch to be initiated in Germany. ...
26 June 2025 - More than 2,000 clinical trial participants contributed to the body of evidence submitted in the new drug ...