8 September 2023 - The submission is based on results from the Phase 3 THOR study, which were featured in ...
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was ...
5 September 2023 - Italfarmaco Group announced today that its marketing authorisation application for givinostat as a potential treatment for ...
5 September 2023 - EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met. ...
30 August 2023 - Regulatory submission based on pivotal data from PANAMO Phase III trial. ...
29 August 2023 - Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical ...
24 August 2023 - Novaliq today announced that the EMA has accepted the marketing authorisation application for CyclASol (ciclosporin ophthalmic ...
18 August 2023 - Leo Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, ...
18 August 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the marketing authorisation application for ...
17 August 2023 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for odronextamab ...
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
18 July 2023 - The EMA has published the letter from Roche on its website. ...
18 July 2023 - Regulatory filing supported by data from two bimekizumab Phase 3 studies in hidradenitis suppurativa. ...
14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase III trial. ...
13 July 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the company's marketing authorisation application for ...