25 April 2024 - CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Tofidence ...
26 April 2024 - Pierre Fabre Laboratories announced that the CHMP of the EMA has adopted a positive opinion recommending approval ...
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 ...
26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
24 April 2024 - Conditional marketing authorisation is based on statistically significant and clinically meaningful results from the Phase 3 ...
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
23 April 2024 - ALPHA Phase 3 trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris ...
22 April 2024 - Emblaveo was reviewed under EMA accelerated assessment procedure, used when a pharmaceutical product is of major ...
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
22 April 2024 - Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD ...
2 April 2024 - Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled ...
27 March 2024 - Otsuka Pharmaceutical announces that its subsidiary Otsuka Pharmaceutical Europe and Lundbeck announced that the European Commission ...