News

Saol resubmitted SL1009 to the FDA for PDCD after added survival analyses, with no new clinical trial reported.

FDA expanded wilate's label to routine prophylaxis in VWD patients aged 6 and up, based on phase 3 WIL-31 data showing an 84% drop in bleeding rate.

If approved, the expanded indication would make roflumilast cream 0.05% the first once-daily, steroid-free topical PDE4 inhibitor approved specifically for this age group.

A new Endocrine Society guideline suggests watchful waiting rather than immediate testing for many girls with early breast development, reserving full evaluation for those with rapid progression or growth acceleration.

About 25% of children with EoE also have joint hypermobility and orthostatic light-headedness, new Lurie Children's data show.

FDA cleared an IND for a NCATS-sponsored AAV9/SUMF1 gene therapy in multiple sulfatase deficiency, moving the ultra-rare disease toward its first-in-human trial.

FDA accepted Pharvaris's NDA for deucrictibant IR, an oral B2 antagonist for HAE attacks, based on phase 3 RAPIDe-3 data.

Pediatricians warn that fireworks, especially sparklers, are a leading cause of preventable injuries in children each summer. Here's what families should know to celebrate safely.

Take a quick look at everything you may have missed in June, including the top FDA approvals and latest clinical updates.

Outdoor meals raise the risk of food poisoning. Here's how families can keep picnics, cookouts and beach days food-safe, from coolers to grill temperatures.

A look back at the FDA approvals, regulatory decisions, and pipeline updates in the pediatric health care space from June 2026.

The July 1, 2026 decision makes exagamglogene autotemcel the first gene therapy approved for SCD in children younger than 12 years.

A new study found a protective lithium coin-cell battery reduced tissue injury, but experts say current emergency treatment should remain unchanged.

A 25-year GUTS cohort study links childhood sugar-sweetened beverage and juice intake to adult hypertension; whole fruit showed no risk.

First RCT in pediatric ARFID finds family-based and individual therapy both cut symptoms; family therapy also drove more weight gain.

A look back at the latest clinical trial updates for the pediatric population during June 2026.

Among children treated with navepegritide throughout the double-blind period, mean TFA decreased from 9.1° at baseline to 7.7° at Week 52 and 6.9° at Week 104, a mean absolute change of −2.2° over 2 years.

FDA expands approval of roflumilast cream 0.3% for plaque psoriasis to children aged 2 years and older, offering the first topical PDE4 inhibitor.

A small study links sequential bilateral TMS to improved depression and suicidality scores in youth with TRD.

A look back at the latest clinical trial updates for the pediatric population during the second quarter (April-June) of 2026.

New AAP guidance recommends age-specific iron deficiency screening, updated ferritin thresholds, and simplified treatment strategies for children.

FDA approved risankizumab for children 6 and older with plaque psoriasis or psoriatic arthritis, adding a weight-based 55-mg syringe for those under 40 kg.

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.