Joshua Fitch, Senior Editor

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.

New phase 3 data show icotrokinra maintained high PASI90 responses in pediatric and adult patients at 1 year.

According to the FDA, infant monitors sold without agency authorization pose safety risks and are not approved to prevent SIDS or SUID.

The agency "tentatively concluded that its use has been abandoned by industry and that the color additive regulation is outdated and unnecessary."

Ibrahim Gwarzo, MBBS, DrPH, MPH, explains his study that found timely opioid administration was associated with lower hospitalization rates for children with uncomplicated sickle cell pain.

The updated label is based on real-world data collected since B-VEC was launched in the United States, following its approval in May 2023.

According to new, real-world data for trofinetide, caregivers reported quality-of-life, alertness, and interaction improvements at 12 months of treatment.

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

Ji-Hyun Lee reports that short surgical exposure to sevoflurane did not affect IQ, behavior, or language outcomes in infants and toddlers.

Capvaxive was superior to PPSV23 for each of the 9 serotypes unique to Capvaxive and non inferior to PPSV23 for the 12 shared serotypes.

Real-world evidence supports neffy as comparable to epinephrine injection in anaphylaxis care.

Results suggest that a single, brief exposure to general anesthesia for surgery is unlikely to impair short-term neurodevelopment in young children.

Prompt opioid dosing in emergency care may reduce hospital stays for children with sickle cell disease pain, new research revealed.

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

Watch our FDA pipeline news recap for the month for August 2025, as well as a preview of PDUFA dates listed for September.