Latest reporting
The FDA Wants to Talk About Psilocybin's Future. It Won't Touch Who's Using It Right Now.
The FDA holds a public hearing today on psilocybin's therapeutic future while explicitly excluding legal status from the agenda — even as poison control calls and unsupervised use keep climbing.
The FDA's Next Psychedelic Hearing Skips the Question That Sank MDMA Therapy
FDA's September 14 hearing covers training and access, not trials — even after new rules for the blinding problem that sank Lykos's 2024 MDMA application.
The FDA Finally Wrote Rules for Psychedelic Trials. Now It Wants to Hear If They're Any Good.
The FDA finalized clinical trial guidance for psychedelic drugs and scheduled a Sept 14, 2026 public hearing — the regulatory infrastructure behind three National Priority Vouchers already issued this year.
Through eight lenses
Science
5-HT2A agonism (classical psychedelics), MDMA serotonin/dopamine/NE release, ibogaine multi-receptor (anti-addiction window).
The FDA Finally Wrote Rules for Psychedelic Trials. Now It Wants to Hear If They're Any Good.
Sep 6The FDA Rejected MDMA Therapy Because It Couldn't Trust the Data. The New Application Doesn't Have New Data.
Sep 1MDMA Therapy's Second Shot at FDA Approval Skips the One Thing That Sank It Last Time
Aug 25
Biology
Acute autonomic effects, serotonin syndrome risk in combos, ibogaine cardiac risk (QT prolongation — real, requires screening), HPPD rare but possible.
Psychology
"mystical experience" correlating with therapeutic outcome (Griffiths et al.); challenging experiences and how they're handled in set/setting.
The FDA Is Finally Asking the Public What It Thinks About Psychedelic Therapy. That Question Was Illegal to Even Study for 40 Years.
Sep 4The FDA Rejected MDMA Therapy Because It Couldn't Trust the Data. The New Application Doesn't Have New Data.
Sep 1MDMA Therapy's Second Shot at FDA Approval Skips the One Thing That Sank It Last Time
Aug 25
Policy
Mostly Schedule I; Oregon Measure 109, Colorado Prop 122, FDA breakthrough designations; MDMA 2024 rejection; state-level initiatives for decrim/regulated access.
The FDA's Next Psychedelic Hearing Skips the Question That Sank MDMA Therapy
Sep 8The FDA Finally Wrote Rules for Psychedelic Trials. Now It Wants to Hear If They're Any Good.
Sep 6The FDA Is Finally Asking the Public What It Thinks About Psychedelic Therapy. That Question Was Illegal to Even Study for 40 Years.
Sep 4
Trends
Psychedelic clinic growth (often off-label ketamine), "microdosing" research (mostly null), ayahuasca tourism.
Treatment
Psilocybin+therapy for AUD (NYU + Hopkins RCTs); ibogaine for OUD (Stanford case series, Kentucky state research); MDMA-AT for PTSD (post-2024 setback, new trials).
The FDA Wants to Talk About Psilocybin's Future. It Won't Touch Who's Using It Right Now.
Sep 14Oregon Has Run the Largest Real-World Psilocybin Experiment on Earth. The First Full Results Are In.
Aug 22Twelve Veterans Had Already Failed Every PTSD Treatment. Nine Are in Remission After Two Doses of Psilocybin.
Aug 1
Harm Reduction
Set/setting, integration, contraindications (SSRIs, heart conditions, family psychosis history for classical psychedelics), test kits.
The FDA Wants to Talk About Psilocybin's Future. It Won't Touch Who's Using It Right Now.
Sep 14People Who Drink and Occasionally Use Psilocybin Score Lower on Depression Scales. Don't Call It a Treatment Yet.
Aug 7FDA's New Psychedelic Trial Rules Don't Reach the Clinics Where Ibogaine Patients Are Dying
Jul 16