News Related to Neurodevelopmental Disorder

Otsuka's ADHD Drug Centanafadine Hits Phase 3b Trial Endpoint Ahead of FDA Decision

Jun 25, 2026

Otsuka's ADHD drug centanafadine met the primary endpoint in a Phase 3b trial in adults with comorbid anxiety, with results supporting its efficacy ahead of a July 24, 2026 FDA decision. The FDA has granted priority review to the New Drug Application for the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). If approved, centanafadine would be a novel treatment option for ADHD in children, adolescents, and adults.

FDA Approves Nivolumab for Pediatric Hodgkin Lymphoma, Clears Two Investigational Drugs for Trials

Apr 03, 2026

The FDA has approved nivolumab with chemotherapy for pediatric and adult Hodgkin lymphoma patients aged 12+, based on clinical trial data showing improved survival. Separately, the agency cleared investigational new drug applications for FG001 for brain cancer surgery visualization and FRF-001 gene therapy for FOXG1 syndrome, allowing both to proceed to clinical trials.

FDA Clears FOXG1 Gene Therapy FRF-001 for Clinical Trials

Feb 16, 2026

The U.S. Food and Drug Administration has approved an Investigational New Drug application for FRF-001, a viral gene therapy for FOXG1 syndrome developed at the University at Buffalo. The first-in-human trial will be independently sponsored by the FOXG1 Research Foundation.