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Arcutis Biotherapeutics announces FDA accepted sNDA for ZORYVE

Arcutis Biotherapeutics announces FDA accepted sNDA for ZORYVE

Arcutis Biotherapeutics (ARQT) announced the FDA’s acceptance of a supplemental New Drug Application, sNDA, forZORYVE cream 0.05%, a once-daily, next generation phosphodiesterase-4 inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of October 13, 2025 for this application.

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