Joshua Fitch, Senior Editor

“We started out 2025 with an environment that was rife with myths and disinformation," said Robert H. Hopkins, Jr., MD, in this year-end recap of 2025 and the pediatric vaccine landscape.

Approval of the expanded indication fullfilled all post-marketing requirements outlined in the original approval letter.

Ferric maltol is now an FDA-approved oral iron therapy for both adults and adolescents with iron deficiency, aged 10 years and older.

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

Once-weekly navepegritide improved growth velocity, skeletal alignment, and functional outcomes in children with achondroplasia, with a favorable safety profile and potential implications for long-term care.

“We started out 2025 with an environment that was rife with myths and disinformation," said Robert H. Hopkins, Jr., MD, in this year-end recap of 2025 and the pediatric vaccine landscape.

The FDA approved fibrinogen, human-chmt to treat acute bleeding episodes in adult and pediatric patients with congenital fibrinogen deficiency.

Abbott received FDA clearance for a new delivery system designed to simplify PDA closure in premature infants weighing as little as 2 lb.

The SWIFT-1 and -2 phase 3 trials demonstrated "significantly" lower rate of annualized asthma exacerbations in patients receiving twice-yearly depemokimab vs placebo.

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

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

Berotralstat becomes the first targeted oral prophylactic therapy for patients with HAE 2 years or older.

According to multiple reports, the FDA is investigating the safety of a pair of already-approved protective treatments for respiratory syncytial virus.

Waskyra becomes the first FDA-approved gene therapy for Wiskott-Aldrich syndrome, offering hope to patients with this rare immunodeficiency.

“We took a different approach by looking at colonizing bacteria, and we found vaccination reduced antimicrobial resistance through a completely different mechanism," said Brooke Ramay, lead author of the study.

The FDA approved omidubicel on December 8, 2025, the same day parent company Ayrmid announced positive results at the 2025 American Society of Hematology Annual Meeting and Exposition.

Marstacimab’s once-weekly subcutaneous administration demonstrated clinically meaningful superiority in key bleeding outcomes for adolescents and adults with hemophilia A or B.

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

"For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age," reads part of vote 1.

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.

“It represents the first time an in vivo HSC-directed gene insertion therapy has been evaluated in a patient," said CEO Jim Burns in a statement.

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

Learn simple strategies to help picky eaters enjoy a balanced Thanksgiving meal through planning, involvement, and a relaxed holiday atmosphere.

The investigational compound centanafadine to treat ADHD in children, adults, and adolescents, is a first-in-class NDSRI.

The clearnace was granted to the Ceribell System for electrographic seizure detection in newborns pre-term and older.

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

A phase 1b study of zelpultide alfa demonstrated a favorable safety profile and encouraging early reductions in BPD and ventilation duration, supporting advancement to a pivotal international Phase 2b/3 program.

The CDC website now claims "studies supporting a link [between vaccines and autism] have been ignored by health authorities."