5 December 2022 - EMA acceptance follows FDA's acceptance of tofersen new drug application earlier this year. ...
2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...
2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...
2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...
14 November 2022 - The MAA was submitted in the EU for toripalimab seeking indications for the first-line treatment of NPC ...
14 November 2022 - New drug application for zilucoplan seeks approval for the treatment of generalised myasthenia gravis in adult patients ...
4 November 2022 - European Commission grants first approval worldwide following positive CHMP opinion in September. ...
31 October 2022 - Santhera Pharmaceuticals announces that the EMA has validated its marketing authorisation application for vamorolone for the treatment ...
28 October 2022 - Marketing authorisation in the European Economic Area anticipated in H1 2023 ...
28 October 2022 - The EMA application is based on the analysis of Phase 3 studies ADvocate 1&2 and ADhere. ...
28 October 2022 - EMA validates AbbVie's marketing authorisation application; Genmab submits biologics license application to US FDA. ...
28 October 2022 - The marketing application is based on results from the HPTN 083 and 084 Phase 2b/3 studies ...
11 October 2022 - Application is based on randomised, controlled and long-term extension data for leniolisib as a treatment for ...
3 October 2022 - Santhera Pharmaceuticals announces that the Company has submitted a marketing authorisation application to the EMA for ...
30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...