28/05/2026 FDA grants Priority Review to Cogent’s bezuclastinib + sunitinib combo in GIST RenovoRx secures FDA Orphan Drug Designation for oxaliplatin in pancreatic cancer Enterome’s EO2463 secures FDA Orphan Drug Designation for indolent NHL FDA grants Priority Review to Cogent’s bezuclastinib + sunitinib combo in GIST (Ref) FDA accepted Cogent’s New Drug Application (NDA) for bezuclastinib + sunitinib in imatinib-pretreated GIST, granting Priority Review with a PDUFA date o

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia ( Ref ) The US FDA granted the Orphan Drug...

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC ( Ref ) The EC approved BeOne Medicines'...

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer ( Ref ) AstraZeneca’s...