What regulatory approvals and designations does Saltikva have?

Not approved anywhere. Fast Track (2022), two FDA Orphan Drug Designations (pancreatic cancer 2022-05-17; osteosarcoma 2025-11-19), and an active FDA IND covering pancreatic cancer, amended to add 11 further solid tumors. The Phase 2 also ran under a Health Canada No Objection Letter.

Last reviewed 2026-11-04