Tag Archive for: European Medicines Agency

Leriglitazone Marketing Authorization Application submitted for treatment of cerebral adrenoleukodystrophy has been validated by European Medicines Agency

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Barcelona, Spain and Düsseldorf, Germany – 23 July 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, today announce that the Marketing Authorization Application (MAA) for Minoryx’s […]

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4SC Files Marketing Authorisation Application with EMA for Resminostat (Kinselby)

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Planegg-Martinsried, Germany, 1 March 2024 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), announced today that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by […]

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4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union

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The European Medicines Agency (EMA) has granted Orphan Drug Designation for resminostat for treatment of cutaneous T-cell lymphoma (CTCL) ODD benefits include 10 years’ market exclusivity in the European Union The Marketing Authorisation Application (MAA) for Kinselby (resminostat) in the EU remains on track for filing in Q1 2024 Planegg-Martinsried, Germany, 18 October 2023 – 4SC […]

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Egetis intends to submit a marketing authorisation application for Emcitate® to the European Medicines Agency based on existing clinical data

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Egetis concludes, based on recent regulatory interactions, that available Triac Trial I data together with recently published long-term data are sufficient for a Marketing Authorisation Application in Europe Having all clinical data required for regulatory submission already at hand significantly reduces the remaining risk for Emcitate Revised submission timelines will be communicated as soon as […]

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