6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...
29 April 2024 - Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression ...
26 April 2024 - If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal ...
26 April 2024 - The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy ...
26 April 2024 - Recommendation based on results from CheckMate-901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate ...
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
28 March 2024 - Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung ...
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...
20 March 2024 - Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in ...
6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...
4 March 2024 - Parallel applications based on TROPION-Lung01 and TROPION-Breast01 Phase 3 trial results demonstrating Daiichi Sankyo and AstraZeneca’s ...
29 February 2024 - Application based on Phase 3 DeFi trial in which nirogacestat significantly improved progression-free survival and objective response ...
28 February 2024 - Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the US, ...