Tag Archive for: EMA

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

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 […]

Destiny Pharma: Positive feedback from European Medicines Agency on XF-73 Nasal gel Phase 3 programme

Positive feedback from European Medicines Agency on XF-73 Nasal gel Phase 3 programme Phase 3 can use similar primary endpoint to the very successful Phase 2b clinical study New European report underpins clinical need and market opportunity of XF-73 Nasal Brighton, United Kingdom, 8 February 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative […]