28 February 2024 - Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the US, ...
26 February 2024 - Recommendation based on results of three Phase 3 clinical trials demonstrating benefit of tislelizumab as a first- ...
26 February 2024 - Recommendation of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial results. ...
23 February 2024 - Positive CHMP opinion is based on pivotal Phase 3 PROTECT study results. ...
23 February 2024 - The EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting. ...
23 February 2024 - If approved, Kalydeco will be the first and only medicine approved in Europe to treat the underlying ...
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first ...
23 February 2024 - In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary ...
23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
19 February 2024 - Velsipity is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 ...
19 February 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
15 February 2024 - The EMA and the Heads of Medicines Agencies have launched two public electronic catalogues: one for ...
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 ...