# LNTH PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/LNTH
Company: Lantheus Holdings, Inc.

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

## LNTH PDUFA Milestones

- 2024-03-01 — FDA Approval — FDA approved application. FDA recorded approval of DEFINITY / DEFINITY RT on March 1, 2024. This list-only historical record is sourced from the official FDA...
  Company: Lantheus Holdings, Inc.
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=21064
  Event detail: https://biopharmsignal.com/pdufa-calendar/LNTH/definity-definity-rt-nda-021064-suppl-33.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/march (March 2024)
- 2025-06-23 — FDA Approval — FDA approved application. FDA recorded approval of NEURACEQ on June 23, 2025. This list-only historical record is sourced from the official FDA application d...
  Company: Lantheus Holdings, Inc.
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204677
  Event detail: https://biopharmsignal.com/pdufa-calendar/LNTH/neuraceq-nda-204677-suppl-24.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025)
- 2026-03-06 — FDA Approval — FDA approved application. FDA recorded approval of PYLARIFY TruVu (piflufolastat F 18) on March 6, 2026. This list-only historical record is sourced from the...
  Company: Lantheus Holdings, Inc.
  Source: https://investor.lantheus.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f
  Event detail: https://biopharmsignal.com/pdufa-calendar/LNTH/pylarify-truvu-piflufolastat-f-18-pylarify-truvu-nda.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026)
- 2026-06-29 — PDUFA — FDA issued a Complete Response Letter. FDA said unresolved inspection-related conditions at the third-party drug-product manufacturing facility prevented app...
  Company: Lantheus Holdings, Inc.
  Source: https://investor.lantheus.com/news-releases/news-release-details/lantheus-receives-complete-response-letter-fda-lnth-2501-ga-68
  Event detail: https://biopharmsignal.com/pdufa-calendar/LNTH/lnth-2501-neuroendocrine-tumor-pet-imaging.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/june (June 2026)
- 2026-08-13 — PDUFA — FDA approved TAUKLARIFY for tau PET imaging. FDA approved TAUKLARIFY (florquinitau F 18), previously known as MK-6240, for PET imaging of the brain in adults...
  Company: Lantheus Holdings, Inc.
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220496
  Event detail: https://biopharmsignal.com/pdufa-calendar/LNTH/mk-6240-alzheimers-disease.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026)

## Related Pages

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

## FAQ

### What does the LNTH PDUFA calendar show?

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

Use the BioPharmSignal company page for LNTH 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.