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Lantheus Gets FDA PDUFA Date For LNTH-2501 Diagnostic Kit In March

October 30, 2025 — 09:40 am EDT

Written by RTTNews.com for RTTNews->

(RTTNews) - Lantheus Holdings, Inc. (LNTH) said Thursday that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2026, for LNTH-2501.

LNTH-2501 is a diagnostic kit used to prepare Ga 68 edotreotide injection, indicated for use with positron positron emission tomography (PET) imaging to localize somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in adult and pediatric patients.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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