Psilocybin Moves the Social Brain in AUD, And Our Trial Endpoints Are Missing It
A pilot RCT links psilocybin's 25 mg dose to reduced egocentric bias in alcohol use disorder, exposing a blind...
Psilocybin MDMA
FDA Hears 80 Speakers on Psychedelic Drug Therapy Standards
The FDA held a public hearing on psychedelic drug therapy, drawing more than 1,800 registered attendees and 80 speakers...
Compass Pathways Just Answered the Durability Question. Now Comes the Harder Problem.
Compass Pathways' 52-week COMP360 data shows 40-45% response rates in treatment-resistant depression. FDA approval in 2027 means nothing without...
The FDA Just Handed Psychedelic Drug Sponsors a Framework. Now the Hard Part Starts.
FDA finalized its psychedelic drug guidance July 14, 2026. COMPASS, Usona, and MAPS now face blinding failures, DEA barriers,...
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...
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...
Psilocybin Works in the Lab. Can It Survive the Clinic?
A UK NHS psilocybin trial exposes the standardization gap threatening psychedelic drug approval — therapist training, setting protocols, and...
Psilocybin Has Crossed the Evidence Threshold. Clinical Guidelines Have Not.
Compass Pathways' Phase 3 six-month data and a first-ever psilocybin-PTSD veteran trial signal readiness — but the guideline infrastructure...
Compass Has Two Positive Phase 3 Trials. The FDA Has Final Guidance. So Why Does Psilocybin Still Feel Like a Gamble?
Compass Pathways' 39% six-month response rate and the FDA's final psychedelics guidance arrive together. The field looks ready. Look...
Psychedelic Trials Are Producing Stunning Numbers. The Methodology Underneath Them May Not Hold.
Luvesilocin's 70% PPD remission rate and psilocybin-CBT pilot data are turning heads—but sex-specific blind spots and a therapy model...