10 November 2023 - The CHMP positive opinion is based on the pivotal Phase 3 MycarinG study in generalised myasthenia gravis ...
10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...
9 November 2023 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival. ...
2 November 2023 - Gedeon Richter together with Sumitomo today announce that the European Commission has granted approval of a type ...
31 October 2023 - The EMA’s CHMP has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of ...
23 October 2023 - Approval based on DESTINY-Lung02 trial results where Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a confirmed objective ...
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 ...
16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...
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. ...