Lantheus Receives Complete Response Letter from FDA for LNTH-2501
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Lantheus regarding its PET diagnostic imaging kit, LNTH-2501, used in the detection of somatostatin receptor-positive neuroendocrine tumors. The FDA cited ongoing issues at a third-party manufacturing site as the reason for not approving the application.
