This week, Contemporary Pediatrics covered topics including an infant formula recall, a warning from the FDA for the SNOO Smart Sleep bassinet, a new FDA approval for Stage 3 type 1 diabetes, and more. Take a look at some of our top stories from the week of June 15 to June 19, 2026, and click on each link to read and watch anything you may have missed.

Tzield approved to preserve insulin production in children with newly diagnosed type 1 diabetes

The FDA expanded approval of teplizumab (Tzield) to include children and adolescents aged 8 to 17 years with recently diagnosed Stage 3 type 1 diabetes, making it the first therapy approved to help preserve endogenous insulin production after clinical diagnosis. The decision was supported by findings from the phase 3 PROTECT trial, which enrolled 328 patients within 6 weeks of diagnosis and demonstrated that teplizumab significantly slowed the decline in beta cell function compared with placebo over 78 weeks, as measured by C-peptide levels.

By preserving residual insulin-producing capacity, the therapy may help improve glycemic control and reduce long-term disease burden during the early stages of type 1 diabetes. Treatment consists of two 12-day courses of intravenous therapy administered 6 months apart. The approval represents an important step in shifting type 1 diabetes management beyond glucose control alone and toward interventions that modify the underlying autoimmune disease process.

FDA and CDC investigating multistate infant botulism outbreak linked to recalled Nara Organics powdered infant formula

A multistate infant botulism outbreak linked to Nara Organics Whole Milk Organic Powdered Infant Formula prompted a nationwide voluntary recall after 3 infants in California, Pennsylvania, and Washington were hospitalized with confirmed botulinum toxin type A infections. All infants received treatment with BabyBIG, the only FDA-approved therapy for infant botulism, and no deaths were reported. Although no recalled formula lots have tested positive for Clostridium botulinum to date, epidemiologic evidence led the FDA to recommend a recall of all product currently on the market.

The cases highlight the continued vulnerability of powdered infant formula to contamination by spore-forming organisms, which are not currently included in routine FDA-required finished-product testing. For pediatricians, the outbreak serves as an important reminder to consider infant botulism in infants presenting with constipation, hypotonia, poor feeding, or progressive weakness and to initiate treatment promptly when clinical suspicion is high, without waiting for laboratory confirmation.

FDA issues Warning Letter to SNOO Smart Sleeper maker over unauthorized sleep sacks, hospital bundle, and quality system failures

The FDA issued a Warning Letter to Happiest Baby, manufacturer of the SNOO Smart Sleeper bassinet, citing multiple regulatory and quality system violations, including the distribution of unauthorized sleep sack sizes, marketing of a hospital-use bundle without FDA clearance, and inadequate handling of product quality complaints. The agency stated that the X-Small and X-Large sleep sacks were introduced without required premarket review and may pose safety risks related to respiratory compromise, suffocation, or unsafe positioning.

FDA inspectors also identified concerns involving mold, unsanitary conditions on refurbished units, and deficiencies in complaint investigations and design validation testing. The Warning Letter further challenges the company's marketing of the SNOO Hospital Bundle for use in clinical settings, despite the device being authorized only for home use. The FDA is advising clinicians and caregivers not to use the unauthorized sleep sack sizes or hospital bundle pending regulatory review and has requested a corrective action plan from the manufacturer.

Acoustic resonance therapy shows promise for pediatric chronic rhinitis

A feasibility study published in OTO Open found that acoustic resonance therapy (ART), delivered through a smartphone-connected wearable device, was associated with improvements in nasal congestion and overall symptom burden among adolescents and young adults with chronic rhinitis. The study enrolled 31 patients aged 12 to 21 years with moderate-to-severe nasal congestion and reported a 35.2% reduction in nasal congestion scores and a 40.5% reduction in Total Nasal Symptom Scores after 2 weeks of treatment. More than 93% of participants reported improvement in congestion symptoms, and adherence to the twice-daily treatment regimen exceeded 85%.

No adverse events were reported. The therapy uses individualized acoustic vibratory energy calibrated to each patient's sinonasal anatomy through a smartphone application and is designed to promote nasal decongestion and mucus clearance through mechanical stimulation. Although the findings are preliminary and derived from a small feasibility study, they suggest that ART may represent a potential nonpharmacologic option for managing chronic rhinitis symptoms in pediatric and adolescent populations.

Vosoritide data support planned FDA submission for hypochondroplasia

At ENDO 2026, BioMarin presented new data supporting its skeletal dysplasia pipeline, including 3-year extension results for vosoritide (Voxzogo) in children with hypochondroplasia and early phase 1 findings for the investigational long-acting CNP analog BMN 333 in achondroplasia. In a small investigator-sponsored extension study involving 13 children with hypochondroplasia, vosoritide treatment was associated with sustained growth improvements over 3 years, including a 0.72 standard deviation increase in height score and annualized growth velocity that remained above baseline throughout follow-up.

The findings add to evidence supporting a planned supplemental FDA application for hypochondroplasia. Separately, phase 1 data in healthy adults showed that BMN 333 achieved prolonged systemic exposure and pharmacodynamic activity consistent with once-weekly dosing, with no dose-limiting toxicities or treatment-related serious adverse events reported. While the vosoritide data provide longer-term evidence of growth benefits in hypochondroplasia, BMN 333 remains in early clinical development, with pediatric efficacy and safety studies ongoing.