8 January 2024 - Approval of this orphan medicinal product is based on pivotal Phase 3 MycarinG study in generalised ...
3 January 2024 - Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term ...
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
27 December 2023 - Formycon and its license partner Klinge Biopharma announce that the EMA has accepted the marketing authorisation application ...
22 December 2023 - Approval based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported by the ...
19 December 2023 - Biogen today announced that the European Commission has revoked the centralised marketing authorizations for generic versions ...
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...
18 December 2023 - The EMA and the Heads of Medicines Agencies have published an artificial intelligence workplan to 2028, ...
15 December 2023 - EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping ...
15 December 2023 - Biogen announced the CHMP of the EMA recommended marketing authorisation for Skyclarys (omaveloxolone) for the treatment ...
17 December 2023 - Astellas contributed to the development of a paediatric formulation to treat schistosomiasis as a member of ...
14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...
14 December 2023 - Apellis Pharmaceuticals announced today an update on the on-going review of its marketing authorisation application for ...
12 December 2023 - The European Commission, the Heads of Medicines Agencies and EMA have published the first version of the ...