News

The FDA has accepted Takeda's supplemental application for IV vedolizumab in patients ages 2 and older with moderate-to-severe UC or Crohn's disease, with a PDUFA date set for Q1 2027.

The FDA has approved an every-8-week maintenance regimen for lebrikizumab-lbkz (EBGLYSS), giving eligible adults and adolescents with moderate-to-severe atopic dermatitis as few as 6 injections per year without mandatory topical therapy.

The FDA has approved bemotrizinol as the first new active sunscreen ingredient under the OTC monograph in nearly two decades, clearing the broad-spectrum UV filter for use in adults and children 6 months of age and older.

FDA designations for investigational GEn-1123 may support development in Duchenne muscular dystrophy, but clinical data remain limited.

New research using a natural experiment design found consistent reductions in diagnosed influenza among vaccinated young children in every season studied from 2016 to 2023.

Vertex reported phase 3 ALYFTREK data in children aged 2 to 5 years with cystic fibrosis and responsive CFTR genotypes.

A cross-sectional study comparing 2 Australian population-based cohorts found that updated infant feeding guidelines recommending egg introduction by 6 months were associated with a 17.7% relative reduction in egg allergy prevalence.

The FDA has broadened the approved indication for marstacimab (Hympavzi; Pfizer) to include pediatric patients ages 6–11 with hemophilia A or B and patients 12 and older with inhibitors.

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

Colleen Cotton, MD, explains how early referral, flare management, and comorbidity screening may help improve outcomes for children with hidradenitis suppurativa.

Jamie Wood, MD, explains how the FDA approval of Afrezza for children aged 6 years and older adds a new mealtime insulin option, offering flexibility beyond injections and pumps.

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

Early referral, school accommodations, and patient education may help improve quality of life for children with hidradenitis suppurativa.

Julie Khlevner, MD, discusses the clinical impact of FDA approval of linaclotide for children aged 2 to 5 years with functional constipation.

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

Colleen Cotton, MD, FAAD, outlines key skin findings that may help pediatricians distinguish hidradenitis suppurativa from other conditions.

An updated consensus statement from the Society for Maternal-Fetal Medicine confirms that acetaminophen remains the safest first-line treatment for pain and fever during pregnancy.

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

Early diagnosis of hidradenitis suppurativa in adolescents may help prevent scarring and improve treatment response, according to Colleen Cotton, MD, FAAD.

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

Kevin Kaiserman, MD, discusses how FDA approval of Afrezza gives children aged 6 years and older with diabetes a new mealtime insulin option.

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

Clear guidance on formula types, safety rules, imported brands, and ingredient fears—plus when switching helps or harms—to reduce anxiety and support healthy growth.

Cedars-Sinai Guerin Children’s launched a wearable asthma monitoring program designed to help detect worsening respiratory symptoms earlier.

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

UCLA researchers identified EPAC2 as a potential Fragile X syndrome treatment target after improving behavioral and brain activity patterns in mice.

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.