The FDA accepted the Anaphylm NDA resubmission as a class 2 response, setting a March 16, 2027, PDUFA date for the sublingual epinephrine film.
News|Articles|April 1, 2025
FDA news in pedatrics: March 2025
Author(s)Joshua Fitch, Senior Editor
A look back at the FDA submissions and regulatory decisions in the pediatric health care space from March 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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DBV filed a BLA for the Viaskin peanut patch in peanut-allergic children aged 4-7, citing phase 3 VITESSE data, and requested priority review.
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.
Black race was the strongest predictor of T2-high inflammation in 451 children with severe asthma adjusted for social and environmental factors.
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.
Diana F. Clarke, PharmD, explains how IMPAACT 2023 supported dolutegravir from birth, plus dosing tips and open questions for preterm infants.
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