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Orphan Drug Designation (ODD)

Showing 4 posts of 4 posts found.

Multiple myeloma treatment approved in Japan

May 21, 2025
Market 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 …

News

FDA approves Incyte’s new anal cancer treatment

May 20, 2025
Research 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 …

News
researchers

Moleculin secures EMA approval to expand acute myeloid leukaemia trial across EU

May 16, 2025
Research 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 …

News

Kaerus Bioscience secures FDA approval for rare genetic disorder treatment

May 15, 2025
Research 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 …

News
The Gateway to Local Adoption Series

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STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases

December 18, 2025

Norgine enters exclusive licensing agreement with Vir Biotechnology

December 18, 2025

Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025