28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...
23 July 2025 - Minoryx Therapeutics and Neuraxpharm today announce that the marketing authorisation application for Minoryx’s lead candidate leriglitazone (Nezglyzal) ...
21 July 2025 - Bristol Myers Squibb today announced that the US FDA has accepted for review the supplemental new ...
10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...
8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...
3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...
27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...
24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA ...
23 June 2025 - Submission based on data from positive GLISTEN Phase 3 trial ...
13 June 2025 - Regulatory decision anticipated H1, 2026. ...
2 June 2025 - The marketing authorisation application submitted to the EMA is based on data from the Pivotal ARES study, evaluating ...
2 June 2025 - Zealand Pharma today announced the submission of a marketing authorisation application to the EMA for glepaglutide, ...
28 May 2025 - 2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...
22 May 2025 - Soleno Therapeutics today announced that Soleno’s marketing authorisation application seeking regulatory approval of diazoxide choline prolonged release ...
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...