27 March 2024 - PRIME status is supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin. ...
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
22 March 2024 - The EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. ...
22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...
22 March 2024 - Positive opinion serves as a basis for final decision for potential authorisation from the European Commission ...
22 March 2024 - Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior haemoglobin improvement in the ...
21 March 2024 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
22 March 2024 - Positive CHMP opinion is supported by data from the two Phase 3 studies, BE HEARD I ...
18 March 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 ...