Morgan Ebert, Executive Editor

Phase 3 SCOUT-HCM results showed mavacamten significantly reduced LVOT gradient vs placebo in adolescents with obstructive HCM.

This recent FDA clearance expands the use of the iotaSOFT Insertion System for pediatric use.

New AAP guidance affirms mother’s own milk as optimal for very low birth weight infants, citing reduced NEC and infection risk and outlining donor milk use.

Maternal influenza and TDaP vaccination during pregnancy was associated with fewer influenza- and pertussis-related hospital and ED visits in infants younger than 6 months.

New dietary guidelines stress whole foods and reduced processing, with expanded, age-specific guidance for infants, children, and adolescents.

ACIP recommends use of GSK’s pentavalent MenACWY-CRM/MenB-4C vaccine when MenACWY and MenB are indicated at the same visit.

FDA approved caplacizumab for pediatric patients ≥12 years with acquired TTP, supported by retrospective data showing 80% remission.

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from December 2025.

View our Q4 2025 recap of standout pediatric news from FDA regulatory updates, clinical trial results, and expert commentary.

Prenatal exposure to hot, humid conditions was associated with significantly reduced child growth, with effects far greater than heat alone.

National EHR data show vitamin K nonreceipt among newborns nearly doubled from 2017 to 2024, raising concern for preventable bleeding risk.

Teen use of alcohol, cannabis, and nicotine remained stable in 2025, while daily energy drink use rose and heroin and cocaine use showed small increases.

A pediatric First Seizure Clinic model reduced time to specialist evaluation to days, enabling earlier diagnosis, testing, and treatment decisions.

Parents support early peanut introduction but remain confused about timing, purpose, and risks, highlighting the need for clearer pediatric guidance.

Phase 3 data show the Viaskin peanut patch improved desensitization vs placebo in children aged 4 to 7 years, supporting a planned FDA BLA in 2026.

The FDA warns retailers over failure to remove recalled infant formula, urging stronger recall practices to protect infants and young children.

A large meta-analysis suggests well-planned vegetarian and vegan diets can support healthy growth in children but require attention to key nutrients.

The FDA has approved Nuzolvence as a new single-dose oral option for uncomplicated urogenital gonorrhea in adults and children 12 years and older who weigh at least 77 pounds.

The FDA approved Daybue Stix, a powder formulation of trofinetide, for Rett syndrome in patients 2 years or older.

Phase 3 results show oral zoliflodacin was noninferior to ceftriaxone and azithromycin for uncomplicated urogenital gonorrhea.

This approval of gepotidacin is the first in a new antibiotic class for the treatment of gonorrhoea approved in over 3 decades.

A comprehensive Pediatrics review reports no credible evidence linking aluminum-adjuvanted vaccines with autism, neurotoxicity, allergy, or autoimmune disease.

State repeals of nonmedical vaccine exemptions were linked to higher kindergarten vaccination rates, with minimal substitution toward medical exemptions.

The ACIP committee voted to pass both resolutions to update its recommendation on the hepatitis B vaccine for infants.

FDA approves expanded indication for MED-EL cochlear implants, allowing use in infants 7 months or older with bilateral SNHL and broadening pediatric eligibility.

Higher maternal vitamin D levels in pregnancy were associated with reduced odds of early childhood caries and lower dmft scores in offspring.

New US modeling study results find nirsevimab would avert the most infant RSV-LRTD events and hospitalizations compared with clesrovimab or RSVpreF maternal vaccination.

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from November 2025.

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

A phase 2b randomized trial found once-weekly navepegritide improved growth velocity, skeletal alignment, and physical functioning in children with achondroplasia.