Zevra Therapeutics submits marketing authorisation application to EMA to review arimoclomol for the treatment of Niemann-Pick disease type C

28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...

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Leriglitazone marketing authorisation application submitted for treatment of cerebral adrenoleukodystrophy has been validated by EMA

23 July 2025 - Minoryx Therapeutics and Neuraxpharm today announce that the marketing authorisation application for Minoryx’s lead candidate leriglitazone (Nezglyzal) ...

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Bristol Myers Squibb’s supplemental new drug application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally

21 July 2025 - Bristol Myers Squibb today announced that the US FDA has accepted for review the supplemental new ...

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Bayer files for EU approval of gadoquatrane

10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...

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New Wegovy dose submitted to EMA for approval, with 1 in 3 trial participants achieving 25% or more weight loss

8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...

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Johnson & Johnson submits application to the EMA seeking indication extension of Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations

3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...

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Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA

27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...

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Philogen provides update on marketing authorisation application for Nidlegy in the European Union

24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA ...

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Linerixibat accepted for review by the EMA for cholestatic pruritus in patients with primary biliary cholangitis

23 June 2025 - Submission based on data from positive GLISTEN Phase 3 trial ...

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GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA to expand use in adults 18 years and older

13 June 2025 - Regulatory decision anticipated H1, 2026. ...

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MaaT Pharma submits marketing authorisation application to the EMA for Xervyteg (MaaT013) in acute graft versus host disease

2 June 2025 - The marketing authorisation application submitted to the EMA is based on data from the Pivotal ARES study, evaluating ...

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Zealand Pharma submits marketing authorisation application to the EMA for glepaglutide in short bowel syndrome

2 June 2025 - Zealand Pharma today announced the submission of a marketing authorisation application to the EMA for glepaglutide, ...

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Pfizer and BioNTech submit EMA application for COVID-19 vaccine targeting LP.8.1 for 2025-2026 season

28 May 2025 -  2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...

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Soleno Therapeutics announces submission and EMA validation of marketing authorisation application for diazoxide choline prolonged release tablets for the treatment of hyperphagia in patients with Prader-Willi syndrome

22 May 2025 - Soleno Therapeutics today announced that Soleno’s marketing authorisation application seeking regulatory approval of diazoxide choline prolonged release ...

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PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer

21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...

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