26 June 2023 - Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients ...
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
23 June 2023 - CHMP recommends approval of the Adtralza pre-filled pen. ...
19 June 2023 - Legacy Healthcare today announced that its marketing authorisation application to the EMA's CHMP for Coacillium for the ...
15 June 2023 - Application Includes Data from Phase 3 FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus ...
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
22 May 2023 - Following the exclusive licensing agreement with Urovant Sciences, Pierre Fabre announced today the start of the ...
19 May 2023 - Sobi today announced that the EMA has accepted and validated a marketing authorisation application for efanesoctocog alfa, ...
10 May 2023 - Marketing Authorization granted for Tibsovo as the first and only approved IDH1 targeted therapy in Europe. ...
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...
25 April 2023 - Regulatory submission based on pivotal data from Part 1 of the RUBY Phase 3 trial. ...
20 April 2023 - Phase 3 data supporting the approval show treatment with Opzelura resulted in improved facial and total body ...