The Epigenetic Clock Is Ticking — But the FDA Hasn’t Set It Yet
No epigenetic aging clock has FDA surrogate endpoint status. Here's the mechanistic gap blocking longevity drug trials—and what sponsors...
FDA Has Authorized 1,500 AI Medical Devices. The Evidence for Most of Them Is Still Catching Up.
Over 1,500 AI-enabled medical devices have FDA authorization, yet rigorous RCT validation trails far behind. Here's the mechanism breaking...
What JAMA’s Causal Language Guidance Actually Says About Difference-in-Differences Studies
JAMA's new guidance on causal language in DiD studies draws a sharp line between association and causation—with direct consequences...
Daraxonrasib’s Resistance Map Is a Blueprint for How Oncology Trials Should Be Designed
Daraxonrasib's Phase 3 data in pancreatic cancer reveals how ctDNA-guided resistance profiling can reshape adaptive trial design—before acquired resistance…
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...
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...
The Recruiter in the Frame: What a Danish RSV Trial Reveals About Who Gets to Invite You Into a Study
A nested trial inside DAN-RSV found that video presenter sex affects adult enrollment decisions, exposing a mechanism most protocol...
The Clinical Trial That Asks Whether Your Current Treatment Should Exist
JAMA's deescalation trial framework forces a reckoning: 22% of prescriptions are unnecessary, and regulators have no standard playbook for...
Long COVID’s Phase 3 Reckoning: What STIMULATE-ICP Reveals About Designing Trials for Diseases Medicine Can’t Yet Explain
STIMULATE-ICP's cluster-randomized Phase 3 design for Long COVID exposes a fundamental tension in trial methodology: how do you randomize...
Nature Medicine’s 2026 Medical AI Superintelligence Framework Signals What FDA Benchmarking Guidance Has Not Yet Addressed
Nature Medicine's July 2026 AI superintelligence framework exposes a critical gap: FDA has no task-based benchmarking standard for medical...