Topical botanical Cinainu earned FDA Breakthrough Therapy status for AA in patients aged 2+, supported by phase 2/3 RAAINBOW data in children.
News|Articles|April 11, 2026
FDA tracker: Novel approvals in pediatrics during 2026
Author(s)Celeste Krewson, Assistant Editor
Fact checked by: Kelly King
A review of 6 novel drugs approved by the FDA, with links to coverage from Contemporary Pediatrics and other MJH Life Sciences brands.
Advertisement
Advertisement
Multiple strides in pediatric care have been reported so far in 2026, marking a transformative year for the treatment of rare pediatric disorders and chronic dermatologic conditions. From the first targeted therapy for neurologic complications in Hunter syndrome and novel interventions for ultrarare diseases such as Menkes disease and arginase 1 deficiency, to historic firsts in oral and topical treatments for plaque psoriasis and atopic dermatitis in children and adolescents, clinical innovation is rapidly expanding the therapeutic tool kit available to pediatricians.
Related to this article
Oral icotrokinra sustained scalp, genital, and hand/foot psoriasis clearance through week 112 in ICONIC-TOTAL, with no new safety signals.
Upadacitinib showed continued facial and body repigmentation in NSV through week 76, with numerically higher responses when combined with NB-UVB.
Christina Boull, MD, explains how pediatricians can recognize dermatologic conditions in darker skin tones and address pigment changes and treatment gaps.
Tezepelumab produced histologic remission in up to 68.9% of patients aged 12+ with EoE vs 3.5% with placebo at week 24, sustained to week 52.
In phase 3 SHINE-2, 50% of mirikizumab induction responders aged 6 to 17 with moderate to severe UC were in clinical remission at week 52.
Christina Boull, MD, shares recommendations for infant skin care, including choosing gentle cleansers, avoiding irritants, and supporting the skin barrier.
Keisha L. Gibson, MD, MPH, discusses the FDA approval of Gazyva for childhood-onset INS and its implications for relapse prevention and pediatric care.
Advertisement
Advertisement