Updates feed.

Last checked 2026-05-16 UTC. Claim boundary: safety/public-health source to retrieve and read before quoting rates or predictors; PubMed title/journal metadata alone should not be upgraded into prevalence figures, causal claims, clinical risk estimates, approval/access claims, or broad safety conclusions.

Last checked 2026-05-16 UTC. Claim boundary: conceptual guideline/protocol-design article only; not clinical outcome evidence, approval, label, reimbursement, access, or proof that systemic involvement improves outcomes. Useful for therapy-model/wiki-source context.

FDA CNPV pilot page excerpt: applications selected for CNPV are subject to the same statutory and regulatory approval requirements; review teams develop independent recommendations; approval decision remains with the relevant product Center.

Reunion release excerpt: ASCP Pharmaceutical Pipeline Session May 26, 2026 2:00-2:10 PM ET; APA poster titled RE104: A Novel Psychedelic Agent for Postpartum Depression. Actual meeting materials pending.

FDA page excerpt in direct scrape: national priority vouchers to companies studying psilocybin for TRD, psilocybin for MDD, methylone for PTSD; no company named for psilocybin/MDD in checked text.

Targeted ClinicalTrials.gov output: Ascend DT120 / Definium Ascend / lysergide tartrate major depressive disorder Ascend = no results; DT120 major depressive disorder returned NCT05407064, not Ascend.

Oregon OPS page excerpt: OPS expects to open administrative rules during the fall of each year; 2026 rulemaking section references RAC/public-comment process. Broader 2026 final rule text not verified in this pass.

Last checked 2026-05-16 UTC. Claim boundary: high-level field-commentary tracker only until full text is reviewed; not clinical evidence, approval/access evidence, safety/efficacy proof, or source for specific factual claims beyond title/journal/date metadata.

PubMed PMID 41621446 / DOI 10.1016/j.jad.2026.121311. Abstract: retrospective inclusion of 233 TRD patients; HAMD and PSQI assessed at 1, 3, and 6 months after first esketamine infusion; PCSL and additional esketamine recorded; HAMD/PSQI scores decreased significantly; response rates 62.00%, 59.73%, 58.49%; no serious adverse events observed during follow-up.

Last checked 2026-05-16 UTC. Claim boundary: observational real-world evidence synthesis only; not new approval, label expansion, reimbursement/access finding, proof of comparative efficacy, or broad safety guarantee. Abstract itself cautions that observational evidence and absence of control groups mean effect sizes should be interpreted with caution.

Last checked 2026-05-15 UTC. Claim boundary: narrative review/knowledge-map item only; it should not be used as proof of human respiratory benefit, broad safety, clinical efficacy, approval, label, reimbursement, or access.

Last checked 2026-05-15 UTC. Claim boundary: nonmedical-use epidemiology and public-health context only; self-report survey correlates are not clinical efficacy evidence, therapeutic safety evidence, approval/access evidence, or a basis for causal claims about LSD.

Last checked 2026-05-15 UTC. Claim boundary: ethnobotany/classification and wiki/source-map item only; not clinical evidence about ayahuasca effects, safety, efficacy, legal access, or medical use.

Last checked 2026-05-15 UTC. Claim boundary: qualitative implementation/guideline-context evidence only; not an efficacy trial, not a broad safety finding, and not evidence of approval/access outside the Australian authorized-prescribing context described by the article.

Last checked 2026-05-15 UTC. Claim boundary: preclinical/basic-neurochemistry rat-brain study only; useful for tightening endogenous-DMT claim boundaries, not for adjudicating human psychedelic experience, clinical efficacy/safety, approval, label, reimbursement, or access.

Abstract: “447 patients receiving acute-phase intravenous ketamine or intranasal esketamine at the MGH Ketamine Clinic were included.” “Pre-treatment network density was significantly higher in non-responders ... compared to responders ...” “Pre-treatment network density serves as a potential correlate of treatment outcomes of ketamine for TRD.”

Abstract: open-label single-arm n=20; chronic suicidal ideation + MDD + >=2 prior antidepressant failures; 25mg psilocybin with support. Week 3 MSSI MD=13.95, 95% CI 8.63-19.27, p<.001; Week 12 70% (n=14) achieved MSSI <=2; no serious adverse events occurred.

Last checked 2026-05-15 UTC. Claim boundary: preclinical mouse neuroplasticity study only; not human addiction, depression, PTSD, Parkinson's, clinical efficacy, broad safety, approval, label, reimbursement, or access evidence.

Last checked 2026-05-15 UTC. Claim boundary: descriptive public-dashboard/service-system analysis only; useful for utilization/equity/safety-monitoring tracker; not a clinical efficacy finding and not proof that services are safe for all uses/populations.

Last checked 2026-05-16 UTC. Claim boundary: company-reported pipeline/capitalization and Phase 3-design tracker only; not approval, label, reimbursement, access, independent efficacy/safety confirmation, or proof that planned Phase 3 studies will start/succeed. Keep BPL-003, VLS-01, and EMP-01 separate from unrelated CNPV/company-primary-pending items.

Last checked 2026-05-15 UTC. Claim boundary: review/registry-map item only; supports wiki/trial-landscape context, not clinical efficacy/safety conclusion, approval, label, reimbursement, or access.

Abstract results: n=35; 17 psilocybin, 18 niacin. Day 8 MADRS between-group difference -7.27; 95% CI -12.89 to -1.65; p=.01. Days 15 and 42 significant; Day 365 no longer significant. No drug-related serious AEs reported; two psilocybin participants reported persistent severe anxiety requiring medical attention.

Abstract: “Ketamine ... has become one of the fastest growing substances of misuse in the UK, with deaths increasing six-fold over the past decade.” “It is now the fifth most commonly used drug among young people...” “presentations frequently occur under the guise of urinary or abdominal symptoms.”

Last checked 2026-05-15 UTC. Claim boundary: company/FDA-process milestone only; CNPV and rolling review are not approval, label, reimbursement, clinical access, or an FDA finding that COMP360 is safe or effective. FDA primary page still names indication categories only and does not name the psilocybin/MDD CNPV company; keep psilocybin/MDD company primary-pending.

Last checked 2026-05-16 UTC. Claim boundary: company-reported topline/backfill only; not peer-reviewed publication, approval, label, reimbursement, access, independent efficacy confirmation, broad safety, or Phase 3 success. Company reports no drug-related SAEs/suicidality-related signals and acute effects ~90 min, but these remain company topline claims from a small signal-detection study.

Last checked 2026-05-16 UTC. Claim boundary: pilot single-site RCT/backfill only; not approval, medical advice, access, label, reimbursement, broad smoking-cessation efficacy proof, or proof of generalizability beyond the studied protocol/population. Abstract reports 40.5% prolonged abstinence in psilocybin group vs 10.0% nicotine patch at 6 months and no psilocybin-attributed serious adverse events.

Compass: “In COMP006, two doses of COMP360 25 mg versus 1 mg demonstrated a highly statistically significant and clinically meaningful reduction ... mean difference of -3.8 ... (p<0.001).” “Across both Phase 3 trials to date, COMP360 is demonstrating a generally well-tolerated and safe profile with no unexpected safety findings.” “Compass has requested a meeting with the FDA to discuss a rolling submission and review and expects to complete an NDA submission in Q4.”