A recap of the top pediatric clinical trial results and pipeline data readouts during October 2026.
News|Articles|September 1, 2025
FDA news in pediatrics: August 2025
Author(s)Morgan Ebert, Executive Editor
Fact checked by: Celeste Krewson, Assistant Editor
A look back at the FDA submissions and regulatory decisions in the pediatric health care space from August 2025.
Advertisement
Advertisement
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.
Related to this article
A recap of the top FDA approvals, regulatory decisions, and pipeline updates affecting pediatric care during October 2026.
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.
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.
Advertisement
Advertisement