# VRTX PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/VRTX
Company: Vertex Pharmaceuticals Incorporated

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

## VRTX PDUFA Milestones

- 2024-01-16 — FDA Approval — FDA approved application. FDA recorded approval of CASGEVY (exagamglogene autotemcel) on January 16, 2024. This list-only historical record is sourced from t...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://news.vrtx.com/news-releases/news-release-details/casgevyr-exagamglogene-autotemcel-approved-us-fda-treatment
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/casgevy-exagamglogene-autotemcel-casgevy-beta-thalassemia-bla.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/january (January 2024)
- 2024-12-13 — FDA Approval — FDA approved application. FDA recorded approval of ORKAMBI on December 13, 2024. This list-only historical record is sourced from the official FDA applicatio...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206038
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/orkambi-nda-206038-suppl-18.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024)
- 2024-12-20 — FDA Approval — FDA approved application. FDA recorded approval of ALYFTREK on December 20, 2024. This list-only historical record is sourced from the official FDA applicati...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218730
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/alyftrek-nda-218730-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024)
- 2024-12-20 — FDA Approval — FDA approved application. FDA recorded approval of TRIKAFTA (COPACKAGED) on December 20, 2024. This list-only historical record is sourced from the official...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212273
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/trikafta-copackaged-nda-212273-suppl-12.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024)
- 2025-01-30 — FDA Approval — FDA approved application. FDA recorded approval of JOURNAVX on January 30, 2025. This list-only historical record is sourced from the official FDA applicatio...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219209
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/journavx-nda-219209-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/january (January 2025)
- 2025-05-22 — FDA Approval — FDA approved application. FDA recorded approval of KALYDECO on May 22, 2025. This list-only historical record is sourced from the official FDA application da...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203188
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/kalydeco-nda-203188-suppl-41.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025)
- 2026-03-27 — FDA Approval — FDA approved application. FDA recorded approval of ALYFTREK on March 27, 2026. This list-only historical record is sourced from the official FDA application...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218730
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/alyftrek-nda-218730-suppl-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026)
- 2026-03-27 — FDA Approval — FDA approved application. FDA recorded approval of TRIKAFTA (COPACKAGED) on March 27, 2026. This list-only historical record is sourced from the official FDA...
  Company: Vertex Pharmaceuticals Incorporated
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212273
  Event detail: https://biopharmsignal.com/pdufa-calendar/VRTX/trikafta-copackaged-nda-212273-suppl-14.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026)

## Related Pages

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

## FAQ

### What does the VRTX PDUFA calendar show?

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

Use the BioPharmSignal company page for VRTX 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.