Nature Medicine Just Published the AI Mental Health Audit Framework the FDA Hasn’t Written Yet
Nature Medicine's clinically validated AI chatbot audit framework arrives as FDA still lacks generative AI mental health approval standards—here's...
RiboX’s Circular RNA CAR-T IND Clearance Forces the Industry to Rethink Everything It Knows About Cell Therapy Trial Design
FDA cleared RiboX's RXIM002 IND for the first circular RNA-based in vivo CAR-T therapy — here's what it means...
FDA Clears IND for RiboX’s RXIM002, Circular RNA CAR-T for ITP
FDA clears IND for circular RNA CAR-T therapy RXIM002, enabling subcutaneous dosing and accelerated Phase 1 trial design for...
AI Drug Discovery Has $8.9 Billion in Hype and Zero FDA Approvals: When Does the Bill Come Due?
AI drug discovery raised $8.9B in 2024, yet no AI-discovered drug holds FDA approval. The gap between algorithmic promise...
David Sinclair Launches Lifespan Media Platform for Longevity Science
David Sinclair launches Lifespan media platform to improve public understanding of longevity science research and clinical trials.
FDA Authorizes CLiK Extra for New World Screwworm Prevention in Livestock
FDA authorizes CLiK Extra for New World screwworm prevention in livestock, marking the third EUA-backed tool in the U.S....
The Brain Is the Frontier: Inside the Trial That’s Rewriting the CAR-T Playbook for Glioblastoma
A Phase 1 trial delivers B7-H3-targeting CAR-T cells directly into the brain of recurrent GBM patients — and the...
CytoSorbents Q2 2026: Flat Revenue, Improved Cash Burn Ahead of DrugSorb-ATR FDA Decision
CytoSorbents pursues FDA De Novo classification for DrugSorb-ATR to address perioperative bleeding in cardiac surgery patients.
Theriva Biologics Doses First Patient in VIRAGE2 Trial of VCN-01 for Metastatic Pancreatic Cancer
Theriva Biologics doses first patient in VIRAGE2 trial of VCN-01 for metastatic pancreatic cancer, testing increased dosing frequency with...
MetaVia’s DA-1726 Reaches Highest Doses in Phase 1 Study Ahead of 2026 Results
MetaVia's DA-1726 reaches highest doses in Phase 1 study with 9.1% mean body weight loss at eight weeks, ahead...