The FDA’s Bayesian Guidance Arrives at Your Site Whether You’re Ready or Not
FDA's January 2026 Bayesian statistics draft guidance reshapes protocol design, interim analysis workflows, and site staffing budgets—here's what operators…
The Specialized Clinical AI Trap: General-Purpose Chatbots Are Winning the Benchmark War
A Nature Medicine study shows general-purpose LLMs outperform specialized clinical AI tools on real physician questions—exposing a validation crisis...
MoonLake’s Sonelokimab Achieves 67% HiSCR75 Response in Phase 3 HS Trial
MoonLake's sonelokimab Phase 3 HS trial shows 67% of adults achieved HiSCR75 response at one year, with a third...
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,...