17 October 2023 - Merck today announced that the CHMP of the EMA has recommended the approval of Prevymis (letermovir) for ...
16 October 2023 - If approved, dostarlimab would become the first new frontline treatment option in the European Union in ...
13 October 2023 - The opinion was based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported ...
13 October 2023 - Final decision from the European Commission expected by the end of 2023. ...
13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...
13 October 2023 - EMA’s CHMP has recommended a conditional marketing authorisation in the European Union for Elrexfio (elranatamab) as a ...
12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...
9 October 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
18 September 2023 - Takeda announced today that the CHMP of the EMA has adopted a positive opinion for the ...
19 September 2023 - This positive opinion reinforces Veklury’s strong safety profile. ...
15 September 2023 - Positive opinion is based on Phase 3 studies which showed long-term response in skin clearance and itch ...
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
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. ...