Joshua Fitch, Senior Editor

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agency "tentatively concluded that its use has been abandoned by industry and that the color additive regulation is outdated and unnecessary."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

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

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.

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

Florida is not aiming to ban vaccinations, but its surgeon general stated "Who am I to tell you what your child should put in [their] body? I don’t have that right."

Arcutis has submitted an sNDA to the FDA for roflumilast cream 0.3% for plaque psoriasis in children aged 2 to 5 years.

Nicotine poisoning can include confusion, vomiting, and loss of consciousness.

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

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

Investigators noted the association was partially mediated by prepubertal adiposity.

If approved, vatiquinone would have been the first therapy approved for pediatric patients with FA.

The AAP recommends that all children aged 6 months to 23 months receive a COVID-19 vaccine, as this group has the highest risk for severe infection.

The AAP stated public health and trauma care should address "needs of injured children across the continuum of care."

Get caught up with Contemporary Pediatrics! This list helps you navigate our top stories from the week, all in 1 place.

Among adolescents aged 13 to 17, coverage with 1 or more Tdap doses increased from 89% to 91.3% from 2023 to 2024.