9 July 2025 - The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding ...
8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...
8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in ...
7 July 2025 - Breakthrough therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in ...
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval. ...
7 July 2025 - First new on demand hereditary angioedema treatment in over a decade, with potential to transform management of the ...
26 June 2025 - Shanghai Vitalgen announced that its gene therapy drug, VGN-R09b, for the treatment of primary Parkinson’s disease, has ...
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 ...
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 ...