5 FDA Updates in Psychiatry from the First Half of 2025

Published Date: 10 Jul 2025

5 FDA Updates in Psychiatry from the First Half of 2025

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FDA Examines Generative AI in Psychiatry, With Hans Eriksson, MD, PhD Hans Eriksson, MD, PhD

As mental health AI tools rise, the FDA weighs benefits and risks, emphasizing oversight and performance testing. Eriksson discusses AI in psychiatric care.

Utilizing Alcohol Use Disorder Pharmacotherapy in Hepatology, With Hersh Shroff, MD, MPA Hersh Shroff, MD, MPA

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The Skin–Brain Axis: Emerging Evidence Transforming Dermatologic Care Lisa A. Swanson, MD, Enzo Berardesca, MD, Mohammad Jafferany, MD

Research reveals a significant skin-brain connection, linking inflammatory skin diseases to neurocognitive and emotional health, particularly in children with atopic dermatitis.

FDA Accepts NDA for Priority Review of Centanafadine to Treat Adult, Pediatric ADHD

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Todays Updates

Can Children With Low-Risk Hodgkin Lymphoma Skip Radiation?

A dose-dense modified Stanford V regimen may improve early complete responses and allow some pediatric patients with low-risk Hodgkin lymphoma to skip radiotherapy.

Older Age Alone Does Not Limit Adagrasib Benefit in NSCLC

In a small phase II study of patients with KRAS G12C-mutated NSCLC, poor performance status, not advanced age, was associated with reduced treatment response.

Todays Updates

Can Children With Low-Risk Hodgkin Lymphoma Skip Radiation?

A dose-dense modified Stanford V regimen may improve early complete responses and allow some pediatric patients with low-risk Hodgkin lymphoma to skip radiotherapy.

Older Age Alone Does Not Limit Adagrasib Benefit in NSCLC

In a small phase II study of patients with KRAS G12C-mutated NSCLC, poor performance status, not advanced age, was associated with reduced treatment response.

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Delay Discounting Fails to Predict MDD Relapse, Q&A With Giles Story, PhD

6 Psychiatry Headlines You Missed in January 2026

As mental health AI tools rise, the FDA weighs benefits and risks, emphasizing oversight and performance testing. Eriksson discusses AI in psychiatric care.

Shroff emphasizes the need to address more than just liver health in patients with alcohol-associated liver disease and reviews trends in AUD pharmacotherapy prescriptions.

Research reveals a significant skin-brain connection, linking inflammatory skin diseases to neurocognitive and emotional health, particularly in children with atopic dermatitis.

FDA Accepts NDA for Priority Review of Centanafadine to Treat Adult, Pediatric ADHD

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Psychiatry in 2025: Year in Review

Psychiatry in 2025: Year in Review

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Adjunctive Lumateperone Significantly Improves MDD Symptoms by Day 43

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4 Psychiatry Headlines You Missed in November 2025

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Mental Health Apps Gain High Uptake but Struggle With Adherence, Retention

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Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children

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Adjunctive Perospirone Safe, Well-Tolerated for MDD in Phase 4 Trial

Adjunctive Perospirone Safe, Well-Tolerated for MDD in Phase 4 Trial

FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years

FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years

Single Dose of MM120 (LSD) Shows Lasting Anxiety Reduction in GAD: Phase 2b Results Chelsie Derman

A phase 2b trial finds a single 100 μg dose of MM120 reduced GAD symptoms with benefits lasting 12 weeks, highlighting the promise of psychedelic therapy.

FDA Releases CRL Detailing Safety Concerns for MDMA-Assisted Therapy in PTSD Chelsie Derman

MDMA’s CRL, now available to the public, cites gaps in safety data, selection bias, and limited durability.

Prenatal Opioid Pain Medications Likely Not Linked to Autism or ADHD Risk Chelsie Derman

A study suggests associations between opioids during pregnancy and neurodevelopmental disorders are mainly due to confounding factors, not causal effects.

Atopic Eczema Linked to Suicidal Ideation in Global Study of 30,000 Adults Chelsie Derman

EADV 2025 findings show patients with atopic eczema face greater risks of depression, anxiety, sleep disorders, and stigmatization.

FDA Initiates Acetaminophen Label Change, Leucovorin Approval for Cerebral Folate Deficiency Abigail Brooks, MA

The Agency initiated an acetaminophen label change to reflect evidence of potential harms in pregnant women and an approval of leucovorin for CFD.

Daily Ammoxetine at 40, 60 mg Outperforms Placebo for MDD in Phase 2 Trial Chelsie Derman

A phase 2 trial demonstrated the effectiveness, safety, and tolerability of ammoxetine (40 and 60 mg) in patients with major depressive disorder.

APhA, Coalition of Autism Scientists Cite Insufficient Data to Support Acetaminophen, Autism Link Abigail Brooks, MA

Both organizations defend the use of Tylenol during pregnancy, citing “rigorous” and “reputable” research suggesting it does not cause autism in children.

5 Psychiatry Headlines You Missed in September 2025 Chelsie Derman

This month in review focuses on innovative therapies in psychiatry, including MM120 for anxiety and ammoxetine for depression, as well as providing safety insights.

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