What FDA’s July 2026 Psychedelic Drug Guidance Actually Says About Trial Design
FDA's finalized psychedelic guidance rewrites the rules on blinding, informed consent, and session monitoring, and the NEJM's September 2026...
Adaptive Clinical Trial Design
What the FDA’s New Psychedelic Framework Actually Means for the Clinic
FDA's September 2026 NEJM framework for psychedelic drugs reshapes trial design, REMS requirements, and patient access for psilocybin and...
Proteomic Aging Clocks Just Changed What a Phase 2a Trial Has to Prove
A Nature Biotechnology phase 2a trial ran six proteomic aging clocks simultaneously, here's what that means for biomarker strategy...
The Algorithm Passed Every Benchmark. The Patients Didn’t Notice.
A landmark Nature Medicine RCT found AI improved clinician decisions but not patient outcomes, exposing the fatal flaw in...
The Mitochondrial Switch That Makes Drugs Different From Food
New Nature Neuroscience data shows MCU inhibition blocks drug reward without touching natural reward circuits, a mechanistic breakthrough for...
The 400-Member Protein Family That Neuroscience Has Almost Entirely Ignored
Nature Reviews Drug Discovery identifies SLC transporters as untapped CNS drug targets, but 97% remain undrugged, and trial designers...
In Vivo CAR-T for CNS Autoimmune Disease Looks Promising. The Trial Design Problem Is Hiding in Plain Sight.
NEJM's lentiviral in vivo CAR-T data in neurologic autoimmune disease is compelling, but the trial infrastructure to validate it...
Reading the COMPARE Phase 1 Data in Nature Medicine Closely
Nature Medicine's COMPARE phase 1 data on CD19 CAR T in refractory RA shows zero severe CRS in 6...
TALENTOP Proved Conversion Surgery Works in Advanced HCC. Now Comes the Harder Question.
TALENTOP's phase 3 data shows liver resection after atezo-bev nearly doubles time to treatment failure in advanced HCC. The...
The Oregon Dataset Is Larger Than the Entire History of Psychedelic Trials. So Why Are Regulators Still Looking the Other Way?
OHSU's 2,363-person Oregon psilocybin dataset dwarfs every RCT in the field's history. Here's what it tells us that clinical...