16 October 2023 - Decision marks fifth approval for Keytruda in lung cancer in the EU. ...
18 October 2023 - Approval based on updated positive overall survival results from the Phase 3 ECHELON-1 study for stage III ...
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 - Agamree could become the first drug fully approved by the EMA for the treatment of patients with Duchenne ...
13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...
13 October 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial. ...
13 October 2023 - EMA’s CHMP has recommended a conditional marketing authorisation in the European Union for Elrexfio (elranatamab) as a ...
13 October 2023 - Fezolinetant is an investigational non-hormonal treatment for vasomotor symptoms associated with menopause. ...
9 October 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
10 October 2023 - Submission to EMA is supported and based on the efficacy and safety evidence gathered in two identical, ...
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 ...
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class ...