# ARQT PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/ARQT
Company: Arcutis Biotherapeutics

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with ARQT.

## ARQT PDUFA Milestones

- 2024-07-09 — FDA Approval — FDA approved application. FDA recorded approval of ZORYVE on July 9, 2024. This list-only historical record is sourced from the official FDA application data...
  Company: Arcutis Biotherapeutics
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215985
  Event detail: https://biopharmsignal.com/pdufa-calendar/ARQT/zoryve-nda-215985-suppl-7.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/july (July 2024)
- 2025-05-22 — FDA Approval — FDA approved application. FDA recorded approval of ZORYVE on May 22, 2025. This list-only historical record is sourced from the official FDA application data...
  Company: Arcutis Biotherapeutics
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217242
  Event detail: https://biopharmsignal.com/pdufa-calendar/ARQT/zoryve-nda-217242-suppl-5.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025)
- 2025-10-04 — FDA Approval — FDA approved application. FDA recorded approval of ZORYVE on October 4, 2025. This list-only historical record is sourced from the official FDA application d...
  Company: Arcutis Biotherapeutics
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215985
  Event detail: https://biopharmsignal.com/pdufa-calendar/ARQT/zoryve-nda-215985-suppl-12.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/october (October 2025)
- 2026-06-29 — PDUFA — FDA approved ZORYVE cream for children as young as 2. FDA expanded the plaque-psoriasis label for ZORYVE cream 0.3% to pediatric patients aged 2 years and ol...
  Company: Arcutis Biotherapeutics
  Source: https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment-0/
  Event detail: https://biopharmsignal.com/pdufa-calendar/ARQT/zoryve-pediatric-plaque-psoriasis.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/june (June 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/ARQT
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the ARQT PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with ARQT, including decision dates, application stage, and summary details when available.
### Where can I find more context for ARQT?

Use the BioPharmSignal company page for ARQT to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.