Arcutis Biotherapeutics announces FDA acceptance of Zoryve sNDA

Arcutis Biotherapeutics announced that the FDA has accepted its supplemental new drug application, or sNDA, for Zoryve cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. The FDA has set a PDUFA target action date of February 23, 2027.