Morgan Ebert, Executive Editor

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.

AAP policy outlines when pediatricians may provide care to parents during child visits, emphasizing benefits, legal considerations, and documentation safeguards.

AAP updates guidance on children’s digital media use, urging child-centered design and system-level action beyond screen time limits.

Three-year EMBARK data show ELEVIDYS slows functional decline in ambulatory Duchenne patients, extending earlier 2-year efficacy findings.

FDA accepted centanafadine NDA for priority review, supported by phase 3 trials showing efficacy in children, adolescents, and adults with ADHD.

AAP updated guidance supports therapeutic hypothermia for term infants with moderate to severe HIE, emphasizing early initiation and specialized care.

The AAP released its 2026 childhood immunization schedule, maintaining evidence-based vaccine recommendations and expanding guidance across routine, catch-up, and risk-based care.

Findings from phase 3 SHORE and COAST 2 trials showed amlitelimab met key efficacy end points in moderate to severe atopic dermatitis, supporting planned regulatory submissions.

FDA-cleared Flowflex Plus 4-in-1 home test detects RSV, influenza A/B, and COVID-19 in adults and children as young as 6 months.

Results from a large US cohort study found no association between community water fluoridation and birth weight, providing reassurance about exposure during pregnancy.

Influenza antiviral use among hospitalized US children declined during the late COVID-19 pandemic despite guideline recommendations.

A national survey found most patients with chronic inflammatory skin disease rely on flare-based care and report concerns about long-term topical steroid use.

Analysis of nearly 900 million hours of monitored infant sleep shows rapid stabilization of sleep patterns in the first year of life.

FDA grants 510(k) clearance to a portable neonatal incubator designed to support thermoregulation and keep preterm infants close to mothers.

A large 2026 meta-analysis found no association between prenatal paracetamol (acetaminophen) use and autism, ADHD, or intellectual disability in children.

The phase 3 SPACE trial showed fremanezumab reduced monthly migraine days vs placebo in pediatric patients with episodic migraine.