18 March 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...
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 ...
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 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first ...