26 February 2024 - Recommendation based on results of three Phase 3 clinical trials demonstrating benefit of tislelizumab as a first- ...
23 February 2024 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...
23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
8 February 2024 - The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically ...
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...
26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...
26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival. ...
16 January 2024 - Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq ...
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...
11 December 2023 - European Commission also converts previous conditional approval for Jemperli to full approval as a monotherapy for ...