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

23/07/2025 Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation (Ref) The European Commission approved Roche's inavolisib (Itovebi; PIK3CA inhibitor) + palbociclib + fulvestrant for the treatment of adult patients with PIK3CA-mutated, ER+ve, HER2-ve, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment The approval is bas