Pediatrics

 
FDA Accepts MannKind sBLA for Inhaled Insulin for Children and Adolescents with Diabetes
October 13, 2025

The sBLA includes data from the phase 3 INHALE-1 study, which showed Afrezza noninferior to MDI insulin. A PDUFA date is set for May 29, 2026.

FDA Expands Indication for Roflumilast to Treat Atopic Dermatitis in Children Aged 2 to 5 Years
October 06, 2025

The approval of roflumilast 0.05% provides a steroid-free, once-daily treatment option for safe and effective long-term management of pediatric eczema.

Measles Outbreak Fails to Push MMR Rates to Herd Immunity Levels, Study Reveals
September 30, 2025

Measles vaccine coverage must reach 93% to maintain herd immunity but in 1 postelimination outbreak, the level reached only 80% in school-aged children.

FDA Approves Guselkumab for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis
September 30, 2025

The FDA has approved guselkumab for children aged 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor authorized for pediatric use.

Leucovorin Close-Up: A Primary Care Primer
September 24, 2025

The FDA has initiated approval of leucovorin calcium tablets for children with cerebral folate deficiency, which can manifest with autistic features. What is it?

Pilot Trial Challenges Routine Steroid Use After Pediatric Anaphylaxis ED Discharge
September 22, 2025

Corticosteroids following resolution of anaphylaxis should be chosen with clear, clinical rationale and reserved for select children, study authors concluded.

FDA Approves Ruxolitinib for Pediatric Patients Aged 2-11 Years as First Topical JAK Inhibitor for the Age Group
September 19, 2025

Incyte announced the agency's decision, which was based on findings of significant reduction in atopic dermatitis signs and symptoms during the TRuE-AD3 clinical trial.

Phase 3 Data Support Efficacy of Delgocitinib Cream in Adolescents With Chronic Hand Eczema; Pooled Analysis Confirms Safety in Adults
September 18, 2025

EADV 2025: New phase 3 data reveal delgocitinib cream's efficacy for chronic hand eczema in adolescents, confirming its safety profile in adults.

Most Parents Trust Standard Childhood Vaccines, but Many Question Flu and COVID-19 Shots: KFF-Washington Post Survey
September 15, 2025

Most parents support childhood vaccines such as MMR and polio, but skepticism about seasonal and newer shots persists, along with distrust of federal agencies.