2 April 2024 - Positive, previously disclosed results from the global Phase 1/2 trial demonstrated genetic and phenotypic correction combined ...
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
28 March 2024 - First marketing authorisation submission for sepiapterin with additional global submissions to follow in 2024. ...
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...
5 March 2024 - MAA validation follows recent applications for seladelpar to the UK MHRA and US FDA. ...
5 March 2024 - MAA submission is supported by positive results from MAESTRO-NASH, the only Phase 3 trial in NASH to ...
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 ...
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
14 February 2024 - Nemolizumab was granted US FDA priority review for prurigo nodularis. ...
13 February 2024 - Celltrion said it has completed its application for marketing authorisation to the EMA for CT-P47, a ...
8 February 2024 - The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically ...
2 February 2024 - Genmab and Pfizer today announced that the EMA has validated for review the marketing authorisation application ...
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...