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.
News|Articles|July 1, 2025
FDA news in pediatrics: June 2025
Author(s)Morgan Ebert, Executive Editor
Fact checked by: Joshua Fitch, Senior Editor
A look back at the FDA submissions and regulatory decisions in the pediatric health care space from June 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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Registry data presented at ASN Kidney Week 2026 linked SCD-PED to higher 90-day survival vs historical controls in pediatric sepsis-associated AKI.
The FDA approved insulin icodec-abae for children 10+ with T2D, based on adult ONWARDS data and a single-dose pediatric pharmacokinetic study.
FDA approves berotralstat 150-mg oral pellets for HAE prophylaxis in patients 12+ who cannot or prefer not to swallow capsules.
Tezepelumab produced histologic remission in up to 68.9% of patients aged 12+ with EoE vs 3.5% with placebo at week 24, sustained to week 52.
In phase 3 SHINE-2, 50% of mirikizumab induction responders aged 6 to 17 with moderate to severe UC were in clinical remission at week 52.
Keisha L. Gibson, MD, MPH, discusses the FDA approval of Gazyva for childhood-onset INS and its implications for relapse prevention and pediatric care.
Topical botanical Cinainu earned FDA Breakthrough Therapy status for AA in patients aged 2+, supported by phase 2/3 RAAINBOW data in children.
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