Centanafadine's ADHD approval, the MDMA NDA resubmission, DT120 phase 3 wins, and the FDA psychedelic hearing headline Q3 2026 psychiatry news.
News|Articles|July 7, 2025
5 FDA Updates in Psychiatry from the First Half of 2025
Author(s)Chelsie Derman
Fact checked by: Victoria Johnson
5 FDA updates in psychiatry from the first half of 2025, plus other pipeline developments in psychiatry for depression, schizophrenia, and OUD.
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The first half of 2025 has brought several important US Food and Drug Administration (FDA) updates in psychiatry, ranging from new drug approvals and label expansions to promising trial data. These developments offer fresh treatment options and improved care strategies for conditions such as depression, schizophrenia, bipolar disorder, ADHD, and opioid use disorder (OUD).
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Here, we review the top psychiatry news in September 2026, from DT120's second Breakthrough Therapy designation to the FDA psychedelic hearing.
Patients with obesity or overweight and T2D saw substantially greater mean weight loss and HbA1c improvement with petrelintide versus placebo.
Remibrutinib doubled complete Total Fric Score response vs placebo at week 12 in RemIND, becoming the first therapy approved specifically for SD.
Presented at EASD 2026, the present analysis discusses CBL-514’s apparent efficacy in reducing L2-L3 visceral fat compared to placebo.
A hepatologist on the lag between drinking and liver disease, metabolic risk, prevention gaps, and when the burden may peak.
Nephrology in Q3 2026: FDA approvals for atacicept, iptacopan, finerenone, and obinutuzumab, plus 2-year IgAN data and CKD screening.
Q3 2026 dermatology recap: FDA approvals in dermatomyositis, adolescent alopecia areata, and sBCC, plus new psoriasis and vitiligo findings.
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