18/03/2026 Idience's venadaparib received the FDA fast track designation for gastric cancer FluoGuide's FG001 imaging agent received the FDA fast track designation for glioma Idience's venadaparib received the FDA fast track designation for gastric cancer (Ref) The US FDA granted the fast track designation to Idience's venadaparib (PARP inhibitor) for the treatment of gastric cancer. Lee Won-sik, CEO, Idience: “This Fast Track designation is highly meaningful in that the FDA

16/03/2026 AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers Telix resubmitted NDA to the US FDA for TLX101-Px brain cancer imaging candidate AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers (Ref) The EC granted approval to AstraZeneca’s durvalumab (anti-PD-L1) + standard-of-care FLOT chemotherapy for the treatment of adult patients with resectabl

12/03/2026 Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma (Ref) The US FDA granted the orphan drug designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG). The Beat Childhood Cancer Research Consortium at Penn State College of Medicine, in partnership with Aminex,

27/10/2025 Cellectar Biosciences' iopofosine I131 received the rare pediatric drug designation for pediatric high-grade glioma (Ref) The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences' iopofosine I131 in inoperable R/R pediatric high-grade glioma (pHGG). The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG James Caruso, President and CEO, Cellectar: “Receiving Rare Pediatric Disease Designation f

07/10/2025 Precision NeuroMed's cinetredekin besudotox received the FDA orphan drug designation for GBM (Ref) The US FDA granted the orphan drug designation to Precision NeuroMed's cinetredekin besudotox (IL13PE38 ; cytotoxic protein) for the treatment of glioblastoma (GBM). The advanced convection-enhanced delivery (CED) platform delivers therapeutic concentrations of cinetredekin besudotox to tumor-infiltrated regions of the brain Sandeep Kunwar, CEO and Co-Founder, Precisi

08/09/2025 Beyond Air's BA-101 received the Orphan Drug Designation for GBM (Ref) The US FDA granted the Orphan Drug Designation to Beyond Air's BA-101 for the treatment of Glioblastoma (GBM). Amir Avniel, CEO, NeuroNOS: “We are pleased to receive orphan drug designation from the FDA for the treatment of glioblastoma. This is our second orphan drug designation and further highlights our mission to bring targeted therapies to individuals and families affected by rare neurologi