Post hoc data show cariprazine improved both manic and depressive symptoms through 52 weeks in youth aged 10 to 17 years with bipolar I disorder.
News|Articles|August 1, 2025
FDA news in pediatrics: July 2025
Fact checked by: Joshua Fitch, Senior Editor
A look back at the FDA submissions and regulatory decisions in the pediatric health care space from July 2025.
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Another month has come and gone, and with it, several FDA approvals and regulatory updates related to the ever-evolving landscape of pediatric health care.
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Cenobamate sNDAs target PGTC seizures in patients ≥12 years and pediatric focal seizures; phase 3 PGTC data showed a 71.9% median reduction.
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In PROGRESS Cohort 2, zilurgisertib reduced total HO volume vs placebo at 24 weeks in children aged 6 to 11 with FOP, with no new HO lesions.
Registry data presented at ASN Kidney Week 2026 linked SCD-PED to higher 90-day survival vs historical controls in pediatric sepsis-associated AKI.
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