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Gallium-68 edotreotide PDUFA Date (Lantheus Holdings)

FDA PDUFA decision date for Gallium-68 edotreotide is March 29, 2026. Developed by Lantheus Holdings. Indication: Somatostatin receptor+ neuroendocrine tumors (PET imaging). Current status: Verifying.

Indication

Somatostatin receptor+ neuroendocrine tumors (PET imaging)

Regulatory details

  • Company: Lantheus Holdings
  • Therapeutic area: Oncology / Nuclear Medicine
  • Application type: NDA
  • Review type: Standard
  • PDUFA date: 2026-03-29
  • Outcome: Pending
Gallium-68 edotreotide PDUFA Date — Lantheus Holdings