News

A look back at the FDA approvals, label expansions, and regulatory decisions in the pediatric health care space from April through June 2026.

A preview of 5 pending FDA decisions for pediatric patients expected in the second half of 2026, spanning ADHD, psoriasis, a metabolic gene therapy, cardiomyopathy, and muscular dystrophy.

A Nemours program trained pediatric residents to conduct autism evaluations, improving confidence and helping families access care sooner.

A multicenter trial found enhanced recovery protocols improved outcomes in pediatric GI surgery when implemented with high adherence.

A new child-protective lithium coin-cell battery reduced esophageal tissue injury in testing, but urgent treatment protocols remain unchanged.

BM-3103 received FDA Fast Track designation for epidermolysis bullosa simplex as a phase 2 trial evaluates safety and efficacy.

Teva's NDA for ecopipam rests on phase 3 data showing a 50% relapse-risk cut, potentially the first new pediatric Tourette mechanism in a decade.

Research suggests childhood factors linked to later menarche may contribute to a wide range of adult health conditions, from heart disease to tobacco use disorder.

FDA approved the first generic rifapentine for active and latent tuberculosis, expanding treatment options for eligible pediatric patients.

Researchers detected multiple endocrine-disrupting chemicals in breast milk and infant urine, highlighting early-life exposure during infancy.

In a parallel regulatory action, the European Medicines Agency has also validated a marketing application for Tivicay covering the neonatal indication.

New FDA-approved options for molluscum contagiosum—in-office cantharidin and at-home berdazimer gel—reduce stigma and avoid painful removal.

Jon Farber, MD, shares his thoughts on a contactless monitoring tool for sleep in Down's syndrome.

Get caught up with Contemporary Pediatrics. This list helps you navigate our top stories from the week, all in one place.

Cadrenal has announced that it plans to seek FDA Rare Pediatric Disease Designation for tecarfarin in children with Kawasaki disease and coronary aneurysms.

A new kids’ series brings fun, physician-led health lessons and representation to underserved families—boosting trust, curiosity, and literacy beyond clinics.

Baloxavir marboxil is a first-in-class cap-dependent endonuclease inhibitor that functions as a prodrug.

Newborn screening speeds SMA treatment, and a first prenatal risdiplam case hints at preventing motor neuron loss before birth.

The approval is based on data from the phase 3 STRIDE-13 trial.

Jon Farber, MD, shares his thoughts on managing renal stones.

New Brain Communications data show doxecitine and doxribtimine reduce mortality risk by up to 94% in early-onset thymidine kinase 2 deficiency.

Learn how early detection and treatments for childhood eczema and hives can curb the atopic march and boost sleep, school, and quality of life.

Jonathan Miller, MD, discusses earlier HPV vaccination, individualized conversations with hesitant families, and strategies to improve vaccine uptake.

BioMarin reports 3-year vosoritide growth data in hypochondroplasia and early BMN 333 findings in achondroplasia.

pCPA gains FDA Orphan Drug Designation for monoamine oxidase deficiency, signaling early development for an ultrarare neurodevelopmental disorder.

Diazoxide choline showed sustained hyperphagia improvements in Prader-Willi syndrome after randomized withdrawal and retreatment.

Setmelanotide reduced BMI measures, fat mass, and hyperphagia scores in interim phase 2 Prader-Willi syndrome data.

A feasibility study found acoustic resonance therapy improved nasal congestion and rhinitis symptoms in adolescents without adverse events.