Tag Archive for: orphan drug designation

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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4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

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The US Food and Drug Administration (FDA) has granted 4SC’s application for Orphan Drug Designation for resminostat (Kinselby) for cutaneous T cell lymphoma (CTCL) Marketing Authorisation Application (MAA) for Kinselby (resminostat) in the EU remains on track for filing in Q1 2024 Planegg-Martinsried, Germany, 27 September 2023 – 4SC AG (4SC, FSE Prime Standard: VSC) received notification […]

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