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Lantheus Says US FDA Pushes Back Review of Diagnostic Imaging Kit
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Lantheus Says US FDA Pushes Back Review of Diagnostic Imaging Kit
Mar 17, 2026 2:34 PM

05:11 PM EDT, 03/17/2026 (MT Newswires) -- Lantheus ( LNTH ) said Tuesday that the US Food and Drug Administration has delayed its decision on LNTH-2501 by three months to June 29 to evaluate additional manufacturing information.

LNTH-2501 is a diagnostic kit for use with positron emission tomography, or PET, imaging to identify neuroendocrine tumors, a type of cancer.

The health regulator's decision to extend its review of the new drug application for the diagnostic kit was not due to concerns about its efficacy or safety, the company said.

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