-+ 0.00%
-+ 0.00%
-+ 0.00%

FDA accepts Arcutis sNDA for Zoryve cream use in infants with atopic dermatitis

PUBT·07/08/2026 12:07:39
Listen to the news
FDA accepts Arcutis sNDA for Zoryve cream use in infants with atopic dermatitis
  • FDA accepted Arcutis’ sNDA for ZORYVE (roflumilast) cream 0.05% to treat mild-to-moderate atopic dermatitis in infants aged 3-24 months.
  • PDUFA target action date set for Feb. 23, 2027.
  • Filing backed by Phase 2 and Phase 1 data showing safety consistent with prior studies, with 34.4% vIGA-AD success at Week 4.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcutis Biotherapeutics Inc. published the original content used to generate this news brief on July 08, 2026, and is solely responsible for the information contained therein.