The FDA cited Happiest Baby, Inc. for distributing unevaluated X-Small and X-Large sleep sacks, marketing its bassinet for hospital use without authorization, and multiple quality system violations including reports of mold and unsanitary refurbished units.
The FDA has approved gadoquatrane (Ambelvist), a next-generation macrocyclic GBCA that delivers effective CNS and whole-body MRI contrast at 60% less gadolinium than standard macrocyclic agents.
Physicians treating infants who consumed Nara Organics Whole Milk Organic Powdered Infant Formula should initiate treatment based on clinical presentation and not await laboratory confirmation.
The FDA granted accelerated approval to teplizumab (Tzield) for children aged 8–17 with recently diagnosed stage 3 T1D, based on PROTECT phase 3 data.
The integrated CGM, first cleared over-the-counter for adults in 2024, is now available without a prescription for people 2 years of age and older who do not use insulin.
Get caught up with Contemporary Pediatrics. This list helps you navigate our top stories from the week, all in one place.
A new Surgeon General advisory links excessive screen use to developmental, mental, physical, and academic risks in children and adolescents.
A CHOP-led study identified IL-6 and IFN-γ immune activation tied to worse recovery in children with sepsis or organ failure.
A first-in-human study of 96 preterm infants shows broadband optical spectroscopy can safely distinguish NEC from healthy tissue within 2 minutes at bedside, without pain or radiation.
Mental health diagnoses are appearing in more pediatric primary care visits, with anxiety showing the largest increase over the past decade.
New ADA 2026 analyses show Afrezza delivered comparable glycemic control, favorable safety, and higher treatment satisfaction in youth.
The FDA has approved expanded indications for tocilizumab-bavi (TOFIDENCE), adding severe or life-threatening CAR T-cell–induced CRS and hospitalized COVID-19 in patients aged 2 years and older.
The FDA has accepted Takeda's supplemental application for IV vedolizumab in patients ages 2 and older with moderate-to-severe UC or Crohn's disease, with a PDUFA date set for Q1 2027.
The FDA has approved an every-8-week maintenance regimen for lebrikizumab-lbkz (EBGLYSS), giving eligible adults and adolescents with moderate-to-severe atopic dermatitis as few as 6 injections per year without mandatory topical therapy.
The FDA has approved bemotrizinol as the first new active sunscreen ingredient under the OTC monograph in nearly two decades, clearing the broad-spectrum UV filter for use in adults and children 6 months of age and older.
FDA designations for investigational GEn-1123 may support development in Duchenne muscular dystrophy, but clinical data remain limited.
New research using a natural experiment design found consistent reductions in diagnosed influenza among vaccinated young children in every season studied from 2016 to 2023.
Vertex reported phase 3 ALYFTREK data in children aged 2 to 5 years with cystic fibrosis and responsive CFTR genotypes.
A cross-sectional study comparing 2 Australian population-based cohorts found that updated infant feeding guidelines recommending egg introduction by 6 months were associated with a 17.7% relative reduction in egg allergy prevalence.
The FDA has broadened the approved indication for marstacimab (Hympavzi; Pfizer) to include pediatric patients ages 6–11 with hemophilia A or B and patients 12 and older with inhibitors.
A look back at the latest clinical trial updates for the pediatric population during May 2026.
Colleen Cotton, MD, outlines a simple screening approach that may help pediatricians identify hidradenitis suppurativa earlier.
Colleen Cotton, MD, explains how early referral, flare management, and comorbidity screening may help improve outcomes for children with hidradenitis suppurativa.
Jamie Wood, MD, explains how the FDA approval of Afrezza for children aged 6 years and older adds a new mealtime insulin option, offering flexibility beyond injections and pumps.
Take a quick look at everything you may have missed in May, including the top FDA approvals and latest clinical updates.
Early referral, school accommodations, and patient education may help improve quality of life for children with hidradenitis suppurativa.
Julie Khlevner, MD, discusses the clinical impact of FDA approval of linaclotide for children aged 2 to 5 years with functional constipation.
FDA approved ensitrelvir for COVID-19 post-exposure prophylaxis in patients aged 12 years and older after positive phase 3 trial results.
Colleen Cotton, MD, FAAD, outlines key skin findings that may help pediatricians distinguish hidradenitis suppurativa from other conditions.
An updated consensus statement from the Society for Maternal-Fetal Medicine confirms that acetaminophen remains the safest first-line treatment for pain and fever during pregnancy.
