Biotech News
FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months
FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027 Application supported by positive results from Phase 2 open-label INTEGUMENT-INFANT study and Phase 1 open-label pharmacokinetic (PK) study 1 million children under the age of 2 are treated topically for