News Related to Neurodevelopmental Disorder

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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.