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.
News|Articles|May 1, 2025
FDA news in pediatrics: April 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 April 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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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.
The FDA accepted the Anaphylm NDA resubmission as a class 2 response, setting a March 16, 2027, PDUFA date for the sublingual epinephrine film.
Diana F. Clarke, PharmD, explains how IMPAACT 2023 supported dolutegravir from birth, plus dosing tips and open questions for preterm infants.
New ecopipam analyses show tic reduction within 8 weeks and sustained to 18 months in Tourette syndrome as the FDA weighs approval.
Oral icotrokinra sustained scalp, genital, and hand/foot psoriasis clearance through week 112 in ICONIC-TOTAL, with no new safety signals.
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