Morgan Ebert, Executive Editor

Common pediatric skin infections are often managed in primary care, but some presentations require dermatology referral and further evaluation.

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

FDA approved ensitrelvir for COVID-19 post-exposure prophylaxis in patients aged 12 years and older after positive phase 3 trial results.

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from May 2026.

The FDA accepted an sNDA for mavacamten in adolescents with obstructive hypertrophic cardiomyopathy, with a decision expected in September 2026.

This decision marks the first FDA-approved inhaled insulin for pediatric patients.

The FDA extended its review of adrabetadex for infantile-onset Niemann-Pick disease type C to November 17, 2026, after a major NDA amendment.

FDA expanded approval of linaclotide for functional constipation to include children aged 2 to 5 years.

New AAP guidance calls for transparent pay practices and family-friendly policies to address gender-based pay inequities in pediatrics.

FDA approval moves adapalene 0.1% and benzoyl peroxide 2.5% gel to OTC use for acne in patients aged 12 years and older.

Ecopipam lowered relapse risk in pediatric Tourette syndrome responders in phase 3 data supporting a planned FDA submission.

Adolescents spent an average of 50 minutes on smartphones during school nights, with social media accounting for most use.

French data suggest dual RSV immunization with RSVpreF and nirsevimab was associated with low infant RSV hospitalization rates.

Phase 3 data showed vosoritide significantly improved annualized growth velocity and height outcomes in children with hypochondroplasia.

FDA accepted a levacetylleucine sNDA for ataxia-telangiectasia and set a September 19, 2026, target action date.

Early phase 2 data suggest zovegalisib may reduce lesion volume and improve symptoms in PIK3CA-driven vascular anomalies.

Early OTC-HOPE data link ECUR-506 to fewer hyperammonemic events in infants with neonatal-onset OTC deficiency.

BMN 401 met a biochemical end point but missed radiographic improvement in a phase 3 trial of children with ENPP1 deficiency.

New AAP guidance highlights layered drowning prevention strategies, including supervision, swim lessons, CPR training, and pool fencing.

High school students who viewed tanning positively or sunscreen use negatively were less likely to practice sun safety

Preclinical data for Gemma's GB703 in DMD and GB221 in SMA1 highlight early gene therapy strategies, but clinical questions remain.

RGX-202 met a microdystrophin biomarker endpoint in phase 3 Duchenne muscular dystrophy data, with functional findings still preliminary.

A UK phase 2b trial will evaluate Lactin-V for preventing preterm birth in pregnant patients at high risk of early delivery.

National pediatric and infectious disease groups convened a measles summit as US cases reached the highest level in 35 years.

For Healthy and Safe Swimming Week, the CDC highlighted key strategies to prevent drowning, pool illnesses, and chemical injuries.

Chronic pediatric skin disorders cause significant stigma, bullying, depression, and suicide risk—conditions often underrecognized and undertreated by physicians.

RVL-001, a vorinostat formulation, has entered early placebo-controlled studies in Rett syndrome and Pitt-Hopkins syndrome.

An international consensus group has recommended renaming PCOS to PMOS to better reflect the condition’s endocrine and metabolic features.

The FDA approved ocrelizumab for pediatric RRMS in patients 10 years and older after positive OPERETTA II trial results.

ABS-1230 entered phase 1b/2 testing for KCNT1-related epilepsy as Actio also joined the FDA Rare Disease Evidence Principles process.