fast-track designation
Marengo’s invikafusp alfa shows promising monotherapy activity in PD-1 resistant gastrointestinal cancers
Invikafusp alfa; Marengo Therapeutics; PD-1 resistant tumors; Gastrointestinal cancers; Colorectal cancer; TMB-H; MSI-H; Immunotherapy; ESMO 2025; FDA Fast Track designation
Diamyd Medical’s Pivotal Phase 3 Type 1 Diabetes Trial Clears Final Safety Review Ahead of Early Readout in March 2026
Diamyd Medical; Type 1 Diabetes; Phase 3 trial; DIAGNODE-3; safety review; Data Safety Monitoring Board (DSMB); interim readout; March 2026; HLA DR3-DQ2 genotype; Orphan Drug Designation; Fast Track Designation; accelerated approval pathway; precision therapy