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 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 Anaphylm NDA resubmission as a class 2 response, setting a March 16, 2027, PDUFA date for the sublingual epinephrine film.
Real-world claims show dupilumab was tied to a 33%-52% lower risk of atopic march progression vs systemic corticosteroids in children with AD.
Once-daily roflumilast cream 0.05% was well tolerated in infants 3 to <24 months with AD, with 34.4% reaching vIGA-AD success at week 4.
At AAP 2026, Peter Lio, MD, discussed distinguishing allergic and inflammatory skin conditions and when pediatricians should seek specialty care.
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.
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.
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