FDA Extends sNDA Review of Ruxolitinib Cream for Kids with AD
Incyte announces that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura, Incyte), a topical Janus kinase (JAK) inhibitor, for the treatment of children 2-11 years old with mild-to-moderate atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date […]