DBV filed a BLA for the Viaskin peanut patch in peanut-allergic children aged 4-7, citing phase 3 VITESSE data, and requested priority review.
News|Articles|April 3, 2025
Q1 2025: A recap of the top headlines and interviews
View our Q1 2025 recap of standout pediatric news from FDA regulatory updates, clinical trial results, and expert commentary.
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As we move into the second quarter of 2025, Q1 brought several treatment regulatory updates and clinical trial results to help better take care of pediatric patients across the globe.
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The FDA accepted the dersimelagon NDA with priority review for EPP and XLP; a decision on the oral MC1R agonist is expected by February 2027.
Aquestive resubmitted its NDA for dibutepinephrine sublingual film Anaphylm, citing new human factors and PK data addressing the FDA's CRL.
Children with atopic dermatitis have higher ADHD risk, particularly with early, severe disease and sleep disturbance, a review found.
Joseph Rossano, MD, discusses how FDA approval of mavacamten introduces a disease-targeted treatment option for adolescents with symptomatic oHCM.
FDA approves Camzyos for pediatric patients with symptomatic obstructive hypertrophic cardiomyopathy
Mavacamten becomes the first cardiac myosin inhibitor approved for adults and pediatric patients weighing 30 kg (66 lbs) or more with symptomatic oHCM.
In a 48-patient phase 1b trial, ecnoglutide was well tolerated in adolescents with obesity and reduced BMI up to 12.6% at 20 weeks.
Can you guess the diagnosis?
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