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,...
Psychedelic Clinical Trials
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...
Lilly’s $2.8 Billion Bet on Psychedelics Buys Science That Conventional Trial Infrastructure May Not Be Able to Run
Eli Lilly acquires AtaiBeckley for $2.8B, but the FDA's final psychedelic trial guidance reveals an operational crisis Big Pharma...
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...
Psychedelic Trials Are Effectively Open-Label. The FDA Has to Decide What to Do With That.
A meta-analysis of 112 psychedelic RCTs found >90% unblinding rates, meaning every efficacy estimate in the field may be...