Joshua Fitch, Senior Editor

The AAP encourages pediatricians to use shared decision-making with families inquiring about leucovorin while providing clear information about available evidence and potential risks.

The FDA has assigned a target action date of February 28, 2026, for a potential expanded indication of pegvaliase-pqpz to include adolescents with PKU.

A pair of phase 3 trials showed that AbbVie's daily upadacitinib 15 mg led to a 50% reduction in T-VASI 50 and a 75% reduction in F-VASI 75 at 48 weeks among adolescents 12 years and older.

In this Q&A, nurse practitioner Tracey Gaslin, PhD, discusses tick bites in pediatric patients, from how to prevent a bite to what to do after a bite, and highlights resources available from the Fight the Bite initiative.

Key highlights from the conference included public health, advocacy for vaccines, and artificial intelligence.

Zoliflodacin study investigator Sarah McLeod, PhD, highlights data presented at IDWeek 2025 in this Q&A with Contemporary Pediatrics.

New one-year data showed that baricitinib continued scalp, eyebrow, and eyelash regrowth in adolescents with severe alopecia areata.

The FDA acknowledged that the primary endpoint was met but that "data do not support the effectiveness of low-dose atropine in children with myopia," according to Sydnexis.

A single injection once per 8 weeks vs once per 4 weeks demonstrated similar levles of skin clearance, for AD patients 12 years and older, according to a Fall Clinical announcement.

New patient- and caregiver-reported outcomes across 3 phase 3 trials demonstrated improved itch and reduced impact of AD on sleep in patients 2 years and older.

Updated 2025 CPR guidelines from the AAP and AHA include revisions to pediatric and neonatal resuscitation, reflecting new evidence and a unified chain of survival.

* Generic lenacapavir could be produced for $25 per person per year at scale, according to an analysis presented at IDWeek 2025 in Atlanta.

Combined or individual use of maternal RSVpreF and infant nirsevimab achieved high antibody levels without safety concerns, supporting current RSV prevention strategies.

Tezepelumab received FDA approval for CRSwNP in patients 12 years and older, supported by strong phase 3 data.

Indication expansions include hidradenitis suppurativa for patients 12 years and up, as well as for patients with uveitis aged 2 years and older.

IDSA’s new GAS pharyngitis guidance emphasizes selective testing using clinical scoring to reduce overtreatment and antibiotic misuse.

In a recent trial, 11 of 12 children treated with DB-OTO demonstrated meaningful hearing gains.

FDA accepts MannKind’s sBLA for Afrezza in children and adolescents with diabetes.

The BeeLine trial is a placebo-controlled study designed to evaluate radiprodil’s impact on both seizure frequency and non-seizure symptoms associated with GRIN-NDD.

The once-daily, steroid-free cream can be used anywhere on the body for treatment and for any duration, according to Arcutis.

Watch our FDA pipeline news recap for the month of September 2025 as well as a preview of a key PDUFA date in October.

View our Q3 2025 recap of standout pediatric news from FDA regulatory updates, clinical trial results, and expert commentary.

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

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

From another potential treatment for pediatric atopic dermatitis, to STI therapy for uncomplicated urogenital gonorrhea, take a look ahead at key PDUFA dates in Q4.

The approval expands on the previous indication of children 5 years and older with HoFH, approved in 2023.

Pediatric influenza-associated deaths for the 2024-25 season were second-highest recorded since becoming notifiable in 2004.

The clinical report replaces a 2010 report, as food allergy impacts up to 10% of children, with anaphylaxis estimated to occur in 1 in 15 schools per year.

A quick look into some of the top sessions occurring at the 2025 American Academy of Pediatrics National Conference & Exhibition, being held from September 26-30, 2025, in Denver, Colorado.