# ROIV PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/ROIV
Company: Roivant

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

## ROIV PDUFA Milestones

- 2026-08-27 — PDUFA — FDA approved LISRAYA for adults with dermatomyositis. FDA approved once-daily oral LISRAYA 30 mg for the treatment of dermatomyositis in adults. FDA describe...
  Company: Roivant
  Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults
  Event detail: https://biopharmsignal.com/pdufa-calendar/ROIV/brepocitinib-dermatomyositis.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026)

## Related Pages

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

## FAQ

### What does the ROIV PDUFA calendar show?

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

Use the BioPharmSignal company page for ROIV 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.