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 ...
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...
11 December 2023 - European Commission also converts previous conditional approval for Jemperli to full approval as a monotherapy for ...
11 December 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
10 December 2023 - First in class treatment option reduces number and intensity of hot flashes and night sweats ...
8 December 2023 - Conditional marketing authorisation is based on clinically meaningful response rates, duration of response, and safety from the ...
5 December 2023 - EMA has relaunched its website: www.ema.europa.eu. ...
4 December 2023 - Approval supported by pivotal Phase 3 RAISE study in generalised myasthenia gravis which demonstrated treatment with zilucoplan ...
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
27 November 2023 - Vyjuvek received orphan drug designation and PRIME designation from the EMA. ...
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...
23 November 2023 - The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking ...
16 November 2023 - IRE) -- Praxis Precision Medicines today announced that the EMA has awarded its Priority Medicines (PRIME) designation ...