2 February 2024 - Genmab and Pfizer today announced that the EMA has validated for review the marketing authorisation application ...
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...
29 January 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability ...
26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival. ...
3 January 2024 - Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term ...
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
27 December 2023 - Formycon and its license partner Klinge Biopharma announce that the EMA has accepted the marketing authorisation application ...
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
27 November 2023 - Vyjuvek received orphan drug designation and PRIME designation from the EMA. ...
24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...
23 November 2023 - The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking ...
20 November 2023 - Anavex Life Sciences announced today that representatives of Anavex met with team members of the EMA. ...