The Oversight Gap Nobody Is Naming: State Sandboxes Are Filling a Void the FDA Has Left Open
Utah's clinical AI sandbox and the FDA's 1,451 AI device authorizations reveal a structural oversight gap—states are building what...
Rogaratinib’s 41.7% Response Rate in SDH-Deficient GIST Rewrites the Playbook for Epigenetically Driven Trial Design
A 24-patient Phase 2 trial of rogaratinib hit 41.7% partial response in SDH-deficient GIST—a tumor that imatinib cures just...
The Cancer Nobody Saw Coming: What One Gene Therapy Tumor Tells Us About a Broken Safety Surveillance System
A rare gene therapy-linked cancer case exposes fatal gaps in long-term safety monitoring—and why FDA's 15-year follow-up mandate isn't...
When Phase 2b Wins and Phase 3 Fails: The Biomarker Stratification Crisis Hidden Inside Astegolimab’s COPD Data
Genentech's astegolimab cut COPD exacerbations in ALIENTO but missed significance in Phase 3 ARNASA—exposing a broken biomarker stratification logic...
Astegolimab’s Split Verdict: What ALIENTO’s Win and ARNASA’s Miss Reveal About COPD Trial Design
Astegolimab cut COPD exacerbations in Phase 2b but missed in Phase 3—a 14.5% gap that exposes critical flaws in...
Europe’s 2030 Clinical Trial Targets Are Already Falling Behind — And the Clock Is Ticking
EMA's first 2026 quarterly report shows only 40.5% of EU trials recruiting within 200 days — far below the...
The IT Neuron Finding That Should Reshape How We Design Rapid-Acting Depression Trials
New Cell data pinpoints intratelencephalic neurons in the anterior insula as the mechanistic key to aiTBS antidepressant effects—here's what...
The TOBRA Trial Just Killed a Widely Used Surgical Assumption — And Most Orthopedic Programs Haven’t Noticed Yet
A 1,660-patient RCT across 39 U.S. trauma centers found tobramycin adds nothing over vancomycin alone for preventing deep SSIs...
Favipiravir Just Beat Ribavirin in Lassa Fever—Now Comes the Hard Part
A Phase 2 RCT published in Nature Medicine shows favipiravir cut Lassa fever mortality with HR 0.50—but the regulatory...
The Alzheimer’s Agitation Approval That Should Rewrite How We Think About Antipsychotics in Geriatric Psychiatry
Auvelity's FDA expansion into Alzheimer's agitation—peak sales now projected at $8B—exposes how long antipsychotics dominated a space where safer...