13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...
13 October 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial. ...
13 October 2023 - EMA’s CHMP has recommended a conditional marketing authorisation in the European Union for Elrexfio (elranatamab) as a ...
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 ...
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class ...
25 September 2023 - Conditional marketing authorisation approval from the European Commission is supported by data from the pivotal Phase 1/2 ...
21 September 2023 - Jazz Pharmaceuticals today announced that the European Commission has granted marketing authorisation for Enrylaze (JZP458; a recombinant ...
19 September 2023 - European Commission approves Tevimbra for previously treated advanced or metastatic oesophageal squamous cell carcinoma. ...
20 September 2023 - Orserdu is the first treatment specifically for patients with oestrogen receptor positive, HER2 negative advanced or metastatic breast ...
18 September 2023 - Takeda announced today that the CHMP of the EMA has adopted a positive opinion for the ...
19 September 2023 - Otsuka and Astex Pharmaceuticals today announce that the European Commission has approved Inaqovi (oral decitabine and ...
18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...
15 September 2023 - Positive opinion based on QuANTUM-First results demonstrating quizartinib combined with standard chemotherapy improved overall survival. ...
15 September 2023 - Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial. ...
15 September 2023 - Recommendation based on DESTINY-Lung02 trial results which showed AstraZeneca and Daiichi Sankyo’s Enhertu achieved strong and durable ...