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...
Psychedelic-Assisted Therapy
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...
LSD Just Beat Phase 3 Twice. Now Comes the Hard Part.
Definium's DT120 cleared Phase 3 in both MDD and GAD. As a ketamine PI who's treated 30,000+ patients, here's...
What a Single-Dose Synthetic Psychedelic Teaches Us About the Limits of Our TRD Trial Designs
A JAMA Psychiatry trial of inhaled mebufotenin in TRD shows rapid antidepressant response, and exposes critical gaps in how...