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. ...
1 December 2023 - The European Medicines Regulatory Network has been at the forefront of the fight against COVID-19 with ...
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 - Valneva today announced that the EMA has performed a technical validation of the marketing authorisation application ...
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 ...
23 November 2023 - More than 1,200 children are newly eligible for a medicine that could treat the underlying cause ...
21 November 2023 - The European Commission has approved pharmaand’s Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer ...
21 November 2023 - Hyrimoz HCF to launch progressively across Europe. ...
20 November 2023 - Anavex Life Sciences announced today that representatives of Anavex met with team members of the EMA. ...