Clinical AI Is Being Deployed Faster Than It Can Be Trusted: Here’s the Network Trying to Fix That
43% of FDA-authorized AI clinical tools lack published validation data. A Columbia-led research network is building the governance framework...
Rezolute’s Ersodetug Misses Congenital Hyperinsulinism Primary Endpoint
Rezolute's ersodetug missed its primary endpoint in congenital hyperinsulinism Phase 3, though expanded access data shows promise in tumor-driven...
Auvelity’s Approval Just Rewrote the Rules for Dementia Agitation Trials
FDA approved Auvelity (dextromethorphan/bupropion) for Alzheimer's agitation with Breakthrough Therapy status, setting a new evidence bar for CNS behavioral…
The Patients We Told Ourselves Were Too Fragile
The STAR trial proves trauma-focused CBT is safe and effective in psychosis/PTSD patients—a dual-diagnosis population psychiatry has systematically excluded…
Connect Biopharma Completes Enrollment in Rademikibart Asthma Study
Connect Biopharma completes enrollment in rademikibart asthma study testing single-dose IL-4Rα antibody during acute exacerbations, with topline data expected...
Teva Submits NDA for Ecopipam in Pediatric Tourette Syndrome
Teva submits NDA for ecopipam in pediatric Tourette syndrome, introducing a D1 receptor antagonist mechanism after a decade without...
An Open Letter to Acting Commissioner Diamantas: The FDA Needs a Regulatory Pathway for Vaccine-Based Dementia Prevention Trials Now
Nature Medicine just made the case for large-scale RCTs of live-attenuated shingles vaccination for dementia prevention. Acting Commissioner Diamantas,...
Zabopegdutide Shows 81.8% Fibrosis Response in Phase 2 MASH Trial
Zabopegdutide demonstrates 81.8% fibrosis response in Phase 2 MASH trial, with AI pathology analysis confirming 41% relative reduction in...
Elicio Reports Three Complete Responses With ELI-002 7P in Metastatic Pancreatic Cancer
Elicio reports three complete responses with ELI-002 7P in metastatic pancreatic cancer patients receiving subsequent checkpoint inhibitor therapy.
uniQure Plans BLA Submission for AMT-130 Gene Therapy in Huntington’s Disease
uniQure plans BLA submission for AMT-130 gene therapy in Huntington's disease, targeting Q3 2026 based on 36-month efficacy data.