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

FDA Unveils ‘Plausible Mechanism Pathway’ to Accelerate Personalized Therapies, Inspired by Baby KJ

FDA; personalized therapies; gene editing; plausible mechanism pathway; Baby KJ; rare diseases; CRISPR; regulatory innovation

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA Plan, Launching Its Hyper-Precise Aortic Care Platform

ViTAA Medical; FDA 510(k) clearance; AiORTA Plan; hyper-precise aortic care; automated aortic surgery planning; vascular AI; preoperative measurement automation; cloud-based healthcare; aortic aneurysm segmentation; clinical workflow improvement

Odyssey Therapeutics Appoints Dennis Dean as EVP, Head of Non-Clinical Development

Odyssey Therapeutics; Dennis Dean; Executive Vice President; Head of Non-Clinical Development; preclinical research; autoimmune diseases; drug development; biopharmaceutical