# EXEL PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/EXEL
Company: Exelixis

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

## EXEL PDUFA Milestones

- 2025-03-26 — FDA Approval — FDA approved application. FDA recorded approval of CABOMETYX on March 26, 2025. This list-only historical record is sourced from the official FDA application...
  Company: Exelixis
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208692
  Event detail: https://biopharmsignal.com/pdufa-calendar/EXEL/cabometyx-nda-208692-suppl-17.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/march (March 2025)
- 2025-09-10 — FDA Approval — FDA approved application. FDA recorded approval of CABOMETYX on September 10, 2025. This list-only historical record is sourced from the official FDA applica...
  Company: Exelixis
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208692
  Event detail: https://biopharmsignal.com/pdufa-calendar/EXEL/cabometyx-nda-208692-suppl-18.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/september (September 2025)

## Related Pages

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

## FAQ

### What does the EXEL PDUFA calendar show?

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

Use the BioPharmSignal company page for EXEL 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.