Joshua Fitch, Senior Editor

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.

Observations were not specific to apitegromab, and the CRL did not cite any other approvability concerns related to efficacy and safety data.

Zilganersen met the primary endpoint of gait stabilization, showing statistically significant benefit on gait speed and favorable safety.

The planned phase 2 study of SAT-3247 will evaluate safety, tolerability, and functional outcomes in children with Duchenne muscular dystrophy.

The federal agency granted accelerated approval to elamipretide HCl to treat patients with Barth syndrome.

The Committee voted against a proposed recommendation that "state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccination.

The Phase 3 SURPASS-PEDS trial found tirzepatide improved glycemic control and weight outcomes in youth-onset type 2 diabetes, with benefits lasting one year.

The FDA has approved an additional indication for Incyte's ruxolitinib cream to include pediatric patients.