Joshua Fitch, Senior Editor

Somapacitan was non-inferior and had a similar safety profile and clinical outcomes compared to once-daily somatropin in improving yearly growth rates.

The nearly 4000 cases in 2023 were the highest number reported in over 30 years, the Task Force stated.

The federal agency provided BioCryst Pharmaceuticals a target action date of September 12, 2025 for potential approval of berotralstat (ORLADEYO).

The administration has set a goal date of October 31 to complete a safety review, public comment period, and to take "appropriate action" in efforts to remove products from the market.

According to the agency, it is seeking public input to "determine whether existing nutrient requirements should be revised based on latest scientific data."

This FDA decision will help to improve clarity and diagnostic accuracy of echocardiograms in pediatric patients, according to GE HealthCare.

Maternal avocado consumption during pregnancy was linked to significantly lower odds of infant food allergy at 12 months.

The in vivo hematopoietic stem cell-directed therapy received rare pediatric disease and orphan drug designations earlier this year.

"Early identification of high-risk neonates may enable targeted strategies to support respiratory health," stated the study investigators.

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

"These findings support Advisory Committee on Immunization Practices’ recommendations for maternal vaccination or nirsevimab to protect against severe RSV disease in infants," wrote the MMWR study investigators.

NEC is a life-threatening condition marked by the death of intestinal tissue, which impacts preterm infants.

Prescriptions for the epinephrine nasal spray are now available for patients aged 4 years and up who weigh 33 to < 66 lbs.

Watch some of our top clips from a number of discussions with experts who presented at PAS 2025.

In this article, we recap our top stories, expert interviews, and Q+A discussions from the 2025 Pediatric Academic Societies meeting.

Stealth BioTherapeutics' CEO stated, "We hope to gain more information on the revised action date in the coming days."

The human FcRn-blocking monoclonal antibody is indicated for gMG patients aged 12 years and older.

The decision makes pz-cel the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB.

In addition, data presented at PAS revealed a predictable pharmacokinetic profile in the newborn population, consistent with adult humans.

One step will be a partnership with the National Institutes of Health to research how food additives impact children's health.

From the FDA approvals of dupilumab and maralixibat tablets to a new puzzler case study, get caught up with our weekly review article.

The CRL issued by the FDA to Regeneron for extended EYLEA HD dosing to 24 weeks cited no safety or efficacy concerns.

The sBLA for dupilumab (Dupixent) was supported by data from the phase 3 LIBERTY-CUPID clinical program in patients with uncontrolled CSU.

Recommendations from the ACIP are forwarded to the director of the CDC, and if adopted, become official CDC policy.

Diazepam nasal spray (Valtoco) is approved for short-term treatment of seizure clusters, now in patients aged 2 years and older.

Recent research detailed that a child was most likely to be killed in a mass shooting by a parent or family member vs a stranger or peer. Study investigator Stephanie Chao, MD, breaks down these data.

In the immediate skin-to-skin contact group, improved breastfeeding practices up to 12 months were observed.

Breastfeeding for 6 months was linked to fewer developmental delays and neurodevelopmental conditions, supporting current recommendations.

Overall, findings revealed that a higher proportion of children with autism had a history of motor milestone delays.

In the United States, maralixibat (Livmarli; Mirum Pharmaceuticals) is approved to treat both ALGS and PFIC, now in liquid and tablet formulations.