Morgan Ebert, Executive Editor

HOPE perfusion showed early graft survival signals in pediatric partial-graft liver transplantation, but data remain limited to small reports.

Pilot study finds maternal dairy intake associated with lower levels of select human milk lipids, with unclear implications for infant health.

FDA testing of 312 infant formula samples found low or undetectable levels of contaminants, supporting safety and ongoing monitoring efforts.

The FDA cleared a generic Infuvite Pediatric injection for children receiving parenteral nutrition, adding a new option for hospital supply.

New AAP guideline replaces “failure to thrive” with “faltering weight,” emphasizing standardized diagnosis and targeted, less invasive care.

Autism diagnoses by primary care providers vary widely by region and state, highlighting disparities in access to specialty care.

Maternal RSV vaccination and nirsevimab were linked to lower infection rates and reduced severity in infants younger than 6 months.

MMR coverage remained below herd immunity 20 months after an Ohio outbreak, with minimal gains and persistent disparities in children.

FDA expands teplizumab (Tzeld) use to children as young as 1 year with stage 2 type 1 diabetes, aiming to delay progression to clinical disease.

Real-world data show pediatric hidradenitis suppurativa treatment relies on antibiotics, with delayed escalation and demographic differences in timing.

A pilot study finds diverse arthritis patterns and high metabolic comorbidity burden in idradenitis suppurativa, with IL-17 inhibitors showing improved outcomes.

David Stukus, MD, discusses nutrition risks, early allergen introduction, and evolving dietary strategies for managing pediatric food allergies.

Phase 3 KEPLER data showed vedolizumab achieved remission in nearly half of children with ulcerative colitis, with consistent safety and durable benefit.

Nontargeted analysis identified 42 PFAS in cord blood, revealing broader prenatal exposure than traditional testing methods capture.

New international pediatric HAE guideline recommends oral sebetralstat as first-line acute therapy for adolescents 12 years and older.

FDA expands pitolisant indication to include cataplexy in patients 6 years and older with narcolepsy.

Ferric maltol gains FDA approval for children 10 years and older with iron deficiency, supported by phase 3 pediatric data.

Experts review key updates to the 2025-2030 Dietary Guidelines for Americans and practical considerations for clinicians.

Phase 2b maintenance data show sustained and new EASI, vIGA-AD, and itch responses with monthly or quarterly rezpegaldesleukin.

In LEVEL UP period 2, most patients who switched from dupilumab to upadacitinib achieved higher skin clearance and itch relief by 16 weeks.

The FDA declined approval of RGX-121 for MPS II, citing concerns about study design, control comparability, and surrogate end point validity.

Global meta-analysis identifies eczema, delayed allergen introduction, and early antibiotics as key food allergy risk factors.

Phase 3 data show that high-dose I-ACQUIRE improved arm function at 6 months in infants and toddlers after perinatal stroke.

FDA grants priority review to marstacimab for hemophilia A or B in children 6 years and older and patients with inhibitors.

FDA and partners are investigating a multistate infant botulism outbreak linked to powdered formula and assessing risks of Clostridium botulinum.

Take a quick look at everything you may have missed this past month, including the top FDA approvals and latest clinical updates.

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from January 2026.

AbbVie submitted FDA and EMA applications for upadacitinib (RINVOQ) in adults and adolescents with non-segmental vitiligo, supported by phase 3 Viti-Up data.

Phase 2 INTEGUMENT-INFANT study results show roflumilast cream 0.05% was well tolerated and improved disease severity in infants with atopic dermatitis.

The FDA has issued a CRL for Anaphylm sublingual epinephrine, citing human factors and PK study needs; resubmission is anticipated in Q3 2026.