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 Designation to ImCheck Therapeutics' ICT01 (anti-BTN3A) for the treatment of acute myeloid leukemia Stephan Braun, CMO, ImCheck Therapeutics: "Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients. This important regulatory m