15 September 2023 - Positive opinion is based on Phase 3 studies which showed long-term response in skin clearance and itch ...
14 September 2023 - Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union ...
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
15 September 2023 - The EMA’s CHMP recommended nine medicines for approval at its September 2023 meeting. ...
15 September 2023 - Positive opinion based on Phase 3 ADAPT-SC study demonstrating non-inferior total IgG reduction at day 29 with ...
15 September 2023 - Positive opinion based on QuANTUM-First results demonstrating quizartinib combined with standard chemotherapy improved overall survival. ...
15 September 2023 - EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a ...
15 September 2023 - Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial. ...
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...
15 September 2023 - Recommendation based on DESTINY-Lung02 trial results which showed AstraZeneca and Daiichi Sankyo’s Enhertu achieved strong and durable ...
15 September 2023 - The CHMP positive opinion is based on the pivotal Phase 3 RAISE study in generalised myasthenia gravis ...
14 September 2023 - EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 ...
7 September 2023 - Milestone signifies on-going effort to help prepare for outbreaks of Zaire ebolavirus. ...
4 September 2023 - SK Bioscience said it has voluntarily withdrawn its application for a conditional marketing authorisation license to ...
30 August 2023 - The EMA’s CHMP has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. ...