10 November 2023 - Recommendation by the CHMP based on positive results from PULSAR clinical trial in neovascular (wet) age-related macular ...
10 November 2023 - The CHMP positive opinion is based on the pivotal Phase 3 MycarinG study in generalised myasthenia gravis ...
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...
30 October 2023 - If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for the first-line treatment ...
27 October 2023 - Egetis Therapeutics today announced that its marketing authorisation application to the EMA for Emcitate (tiratricol) for ...
27 October 2023 - ImmunoGen today announced that the EMA has accepted the marketing authorisation application for mirvetuximab soravtansine (Elahere) ...
25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...
24 October 2023 - Orphelia Pharma today announces the filing of a centralised marketing authorisation application to the EMA for ...
23 October 2023 - Ipsen plans to submit a new marketing authorisation application for the treatment of Alagille syndrome by the ...
10 October 2023 - Submission to EMA is supported and based on the efficacy and safety evidence gathered in two identical, ...
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 ...
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class ...
28 September 2023 - Submission to the CHMP for full approval is based on the full two-year data set from the ...
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...