MarketPulse

pediatric indication

5 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Arcutis Reports 65% YoY Growth in ZORYVE Revenue Despite Seasonal Decline

Arcutis reports Q1 2026 ZORYVE revenue of $105.4 million, up 65% year-over-year, with expanded pediatric development and reaffirmed full-year guidance of $480-495 million.
ARQTFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Sanofi And Regeneron

Dupixent Wins FDA Nod for Young Children With Chronic Urticaria, Expanding Market Reach

FDA approves Dupixent for children ages 2-11 with uncontrolled chronic spontaneous urticaria, marking first biologic treatment for this pediatric population.
SNYREGNchronic spontaneous urticariaFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Sanofi

Sanofi's Tzield Wins FDA Nod to Treat Type 1 Diabetes in Infants as Young as One

FDA approves Sanofi's Tzield for children as young as one with type 1 diabetes, marking first disease-modifying therapy for this young cohort.
SNYFDA approvalType 1 diabetes
GlobeNewswire Inc.GlobeNewswire Inc.··Na

BioCryst Achieves Historic Profitability as ORLADEYO Revenue Surges 38%

BioCryst achieved historic profitability with ORLADEYO revenue surging 38% to $601.8 million. FDA approval for pediatric formulation and Astria acquisition expand HAE treatment portfolio.
BCRXFDA approvalprofitability
BenzingaBenzinga··Vandana Singh

Merck Seeks to Expand RSV Antibody Approval Following Positive Phase 3 Trial Results

Merck's RSV antibody Enflonsia shows positive Phase 3 results, supporting FDA expansion plans to protect more at-risk infants from respiratory syncytial virus infection.
MRKGSKmonoclonal antibodyFDA approval