Arcutis Biotherapeutics submitted a supplemental New Drug Application (sNDA) to the FDA to expand the indication for its drug ZORYVE.
6 reports, 4 independent
Updated Oct 9
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What happened
Arcutis Biotherapeutics submitted a supplemental New Drug Application (sNDA) to the FDA to expand the indication for its drug ZORYVE.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA is reviewing Arcutis' ZORYVE for infant treatment.1 source
Arcutis Biotherapeutics seeks expanded indication for ZORYVE via sNDA submission.1 source
- ZORYVE is FDA-approved for mild to moderate Atopic Dermatitis, following strong AAD recommendation.
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Coverage
Newest first; wire copies grouped- manilatimes.net
- dailypolitical.com
- empr.com
- GlobeNewswireArcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5 If approved, ZORYVE cream would b
- GlobeNewswireArcutis Announces Second Quarter 2025 Financial Results and Provides Business Update Q2 2025 net product revenue for ZORYVE® (roflumilast) was $81.5 million, a 164% increase compared to Q2 of 2024, a
- Unknown outlet