Research, harm reduction, and community insights on psilocybin, psychedelic wellness, and the evolving legal landscape.
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A promo for a $20 after-party in Silver Spring is not the story. The story is the hearing it followed: FDA's first broad public session on how a legal psilocybin medicine would actually be delivered, held while Compass Pathways races to finish a rolling NDA — and while a JAMA Psychiatry review says the trials underneath all of it are functionally unblinded.
At FDA's September 14, 2026 public hearing on psychedelics, a chronic-pain advocate argued that the non-drug parts of a session — touch, neuromodulation, physical therapy — are doing real work, and that pain deserves a seat at a table FDA has set for psychiatry. The argument is reasonable. The evidence base under it is one case report, three tiny trials, a null result against active placebo, and a mouse study.
Two years after the Complete Response Letter, the company formerly known as Lykos has resubmitted MDMA-assisted therapy for PTSD — and it did not run the new Phase 3 trial the FDA recommended. It is leaning on third-party data, a fresh safety study, and a friendlier regulatory climate instead.
In one week the VA launched a five-site COMP360 trial for veterans, FDA finalized psychedelic clinical-investigation guidance and set a September 14 hearing, and ICON hired Anthropic’s Claude for trial operations.
New regulations allow more service centers to open statewide, making legal psilocybin therapy accessible to thousands more residents.
Following voter approval, licensed psilocybin healing centers begin welcoming clients in Denver and Boulder.