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Arcutis Biotherapeutics announces FDA acceptance of sNDA for ZORYVE

Arcutis Biotherapeutics (ARQT) announced the FDA acceptance of a supplemental New Drug Application, sNDA, for ZORYVE cream 0.3%, a once-daily, advanced targeted topical phosphodiesterase-4 inhibitor, to expand the indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old. The FDA has set a PDUFA target action date of June 29, 2026, for this application.

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