REGULATION · ANALYSIS

Nine in ten public comments on FDA's five most-commented reviews favor approval. The outcomes did not follow.

A Johns Hopkins team coded 600 public comments from the five most-commented FDA reviews of 2020 to 2024 and found 90.2 percent supported approval. Its own appendix of 44 advisory committee reviews shows comment volume tracking committee votes in no consistent way. In the five cases, FDA's documents point to other grounds, among them inspections, manufacturing comparability, durability data, post hoc analyses and one Center Director override of his own reviewers.

By Editorial Desk · 12 min read

Across the desks

PSYCHEDELICS · REGULATION

FDA's preliminary thinking on a first ibogaine trial calls for a cardiac unit, a genotype screen and patients taken off methadone

In a request for information published October 6, FDA described the early-phase ibogaine trial it is considering: single ascending doses up to 10 mg/kg, given one participant at a time in an inpatient unit equipped to treat a life-threatening arrhythmia. The notice sets no requirements. It does show what a sponsor would likely need under that approach, and the first item is a hospital, which neither funding nor drug supply provides on its own.

By Editorial Desk · 9 min

REGULATION

VA says it will require signed consent before antidepressants for veterans under 30. The FDA's labeled risk band ends at 24.

Starting in 2027, VA plans to require a signed consent form before prescribing an antidepressant to a veteran younger than 30. Ten months earlier it told the Senate a broader signature mandate could delay care. It has not explained the age line, and the FDA's own trial analysis did not find added suicidality risk at ages 25 to 34.

By Editorial Desk · 8 min

DIGITAL HEALTH · MARKETS

The first FDA-approved at-home depression device goes on sale in the US, nine months after approval

Flow Neuroscience's FL-100 headset is the only tDCS device with a completed FDA premarket approval for depression; its closest tDCS rivals are still in investigational trials. The commercial launch adds a prescription and telehealth pathway to that approval. It does not add a price, an insurance answer, or independent data on how the device performs outside a clinical trial.

By Editorial Desk · 5 min

PSYCHEDELICS · REGULATION

The psychedelic approval debate is moving from whether the drugs work to who must deliver them

FDA's September 14 public hearing opened with five minutes on executive orders and priority vouchers, then turned to a two-hour comment block on a narrower question: who has to be in the room when a patient takes the drug. This account covers the opening remarks and twenty of that block's speakers. Not one of them drew a question from FDA's panel.

By Editorial Desk · 11 min

Analysis

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PSYCHEDELICS · ANALYSIS

Psilocybin's next indication frontier may be pain. The programs chasing it are not testing the same thing.

Cancer pain, chronic pelvic pain, phantom limb pain, fibromyalgia, migraine: psilocybin trials are now running across a genuinely wide swath of chronic pain medicine. Nearly all of them share the same structural weakness, a pain-scale endpoint that cannot tell whether the drug changed the pain itself or changed how much the pain bothers the patient. That distinction is the entire story.

Editorial Desk · 9 min read

PSYCHEDELICS · ANALYSIS

Real-world psilocybin data is starting to arrive. It looks a lot more like an SSRI than a breakthrough.

A retrospective study of 19 patients treated under Switzerland's limited medical-use exemption is among the first real-world psilocybin outcome data generated outside a clinical trial. The response and remission rates land close to what ordinary antidepressants achieve in real-world use, not the dramatic figures the field's early trials reported.

Editorial Desk · 8 min read

DIGITAL HEALTH · ANALYSIS

At-home ketamine's largest dataset reports strong results. Six of seven authors are paid by the company it studies.

A retrospective analysis of 3,041 Mindbloom patients reports high rates of clinical improvement from at-home subcutaneous ketamine, a genuinely under-studied delivery route. The topline numbers are real. So is the conflict of interest, the near-total attrition by the final assessment, and the gap between the headline improvement rate and the much lower remission rate underneath it.

Editorial Desk · 8 min read

The work

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Draulio B. Araújo · Professor, Brain Institute, Federal University of Rio Grande do Norte · Director, Centro Avançado de Medicina Psicodélica

From ayahuasca to DMT: Draulio Araújo on why a negative trial would still advance the science

Draulio B. Araújo's research moved from studying consciousness during the acute ayahuasca experience to a randomized trial in treatment-resistant depression, and now to an ongoing Phase 2b DMT study built specifically to find out whether that early signal survives blinding, an active comparator, and outcomes that go beyond a symptom scale.

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In the pipeline

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Last updated Nov 9, 2026

Pharma Approved

Zuranolone (Zurzuvae)

Postpartum depression

Marketed for PPD; not approved for MDD in the U.S.

Updated Apr 18, 2026

Pharma Approved

AXS-05 (Auvelity)

Major depressive disorder

Marketed

Updated May 9, 2026

Pharma Approved

AXS-05 (Auvelity)

Agitation associated with dementia due to Alzheimer's disease

FDA approved April 2026

Updated Apr 30, 2026