Orphan Drug Designation (ODD)
Multiple myeloma treatment approved in Japan
May 21, 2025Market Access, Research and Development, Sales and Marketing GSK, Japan, Oncology, Orphan Drug Designation (ODD), multiple myeloma
GSK’s Blenrep (belantamab mafodotin) combinations have been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of …
FDA approves Incyte’s new anal cancer treatment
May 20, 2025Research and Development FDA, Incyte Corporation, Oncology, Orphan Drug Designation (ODD), Zynyz, fast track designation, priority review
The US Food and Drug Administration (FDA) has approved Incyte Corporation’s immunotherapy retifanlimab-dlwr (Zynyz) in combination with carboplatin and paclitaxel to treat …
Moleculin secures EMA approval to expand acute myeloid leukaemia trial across EU
May 16, 2025Research and Development Clinical Trial Application (CTA), European Union (EU), FDA, Food and Drug Administration, Moleculin Biotech, Oncology, Orphan Drug Designation (ODD), acute myeloid leukaemia
Moleculin Biotech has received approval from the European Medicines Agency (EMA) to expand its phase 3 ‘MIRACLE’ trial into nine …
Kaerus Bioscience secures FDA approval for rare genetic disorder treatment
May 15, 2025Research and Development FDA, Fragile X syndrome, Kaerus Bioscience, Orphan Drug Designation (ODD), Rare Diseases, Rare Pediatric Drug Designations (RPDD), genetic syndromes
Kaerus Bioscience announces that its lead candidate KER-0193 has been granted both Orphan Drug Designation (ODD) and Rare Pediatric Drug …
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FibroFind appoints Lee Borthwick as CEO
July 21, 2026
