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Though the decision will not meet the June 17, 2025, target date, the federal agency anticipates a decision within approximately 4 weeks.

The approval for ustekinumab-stba now offers all dosage forms to the reference product, ustekinumab, and is indicated for patients aged 6 to 17 years.

Research presented at NUTRITION 2025 shows that fathers with improved adolescent diets are more likely to model and monitor healthy eating for their children.

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Currently, Vimkunya is FDA-approved for use among individuals aged 12 years and older.

A recent study found screen time and socioemotional problems in children are linked in both directions, with gaming tied to greater risk than other activities.

Michael O. Daines, MD, outlines key diagnostic criteria and treatment challenges for pediatric acute-onset neuropsychiatric syndrome (PANS), emphasizing the need for multidisciplinary care and improved treatment access.

Glecaprevir/pibrentasvir was a "highly efficacious treatment for people with acute HCV," with 96.2% of patients analyzed having sustained virological response 12 weeks post-treatment.

Aaron Milstone, MD, MHS, emphasizes the role of pediatricians in educating families on infection prevention practices for infants in the NICU, where Staphylococcus aureus remains a serious threat.

Childhood adversity may raise endometriosis risk, with exposure to violence linked to a twofold increase, a Swedish study of 1.3M women finds.

The phase 2 trial will be 4 weeks and evaluate investigational, once-daily roflumilast cream 0.05% in infants 3 months to less than 2 years of age.

Ramilo, a clesrovimab clinical trial investigator, breaks down the recent FDA approval for the newest monoclonal antibody to protect against RSV disease in infants.

The BLA for clesrovimab was based on results demonstrated in the phase 2b/3 CLEVER trial among healthy pre-term and full-term infants.

Results at 24 weeks revealed that 76% of individuals achieved a 75% or more improvement in overall disease severity (EASI-75), trial's primary endpoint.

The combination therapy yielded boosted treatment benefits of navepegritide, including improvement in mean ACH Z-score and mean annualized growth.

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

Aaron Milstone, MD, emphasizes the need for better recognition and prevention of Staphylococcus aureus infections in neonatal intensive care units.

The authors noted that comparisons between PDA management strategies is crucial for informing optimal approaches to the PDA.

Six-month results from the phase 2 VLA1553-221 trial aligned with initial data and demonstrated immune response at day 180 among patients aged 1 to 11 years.

Aaron Milstone, MD, explains that very low birth weight infants remain disproportionately affected by deadly Staph aureus infections in NICUs.

Unlike conventional carrier screening that estimates generic reproductive risk, the UNITY panel offers a direct fetal risk estimate.

The data found complements state- and national-level CDC data, confirming widespread declines in MMR vaccination rates.

Children with blood lead levels below CDC intervention thresholds had lower test scores through adolescence, a new study showed.

The AI-enabled, wearable device is the first FDA-approved, drug-free solution for nasal congestion and allergies in children ages 12 and up.

Infant is closely monitored at subsequent well visits and rechecked after 3 months, showed full resolution of the skin lesion over the heel area.

Study results could guide future approaches to optimize service line definitions, according to the study authors.

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