U.S. FDA Accepts sNDA for Roflumilast Cream for PsO in Young Kids; PDUFA Date Set for June 29, 2026.
The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.3% (Zoryve, Arcutis) to treat plaque psoriasis in children aged 2 to 5.