Joshua Fitch, Senior Editor

The American Academy of Pediatrics warns families to avoid home fireworks and offers safer alternatives to prevent injuries, especially in young children.

Additionally, long sleep duration could be associated with increased odds of being reliably symptomatic at 4 weeks.

Data from the study suggest caretakers of CPP patients be vigilant for psychiatric symptoms to begin care at an early stage.

The revised labeling will warn that patients younger than 6 years taking these medications are at greater risk of weight loss.

The updated labeling includes a new contraindication for patients with prior or active hepatic events.

MNV-201 is being evaluated in phase 2 clinical trials for treatment of the ultra-rare, life-threatening mitochondrial disorder affecting children.

The total number of pediatric mental health hospitalizations declined in 2022, the first time observed since 2009.

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New phase 3 data support marstacimab’s efficacy and safety in treating hemophilia A or B with inhibitors, expanding its potential use.

The final recommendation sign off decision will go to HHS secretary Robert F. Kennedy Jr.

The American Academy of Pediatrics will continue to hold its own childhood vaccine schedule, as it has since the 1930s.

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Lenacapavir is the first twice-yearly option available in the US for those who need or want PrEP, according to Gilead Sciences.

Currently, omaveloxolone (Skyclarys) is approved to treat adults and adolescents aged 16 years and older impacted by FA.

The federal agency has assigned a target action date of January 31, 2026, for a decision.

Garadacimab-gxii is the only treatment to target factor Xlla for prophylactic use to prevent attacks of HAE in patients aged 12 years and older.

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.

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

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.

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.

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.

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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.

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

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