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On Friday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Lantheus Holdings Inc.’s (NASDAQ: LNTH ) New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors. FDA Issues Complete Respons
Lantheus Holdings shares are trading lower after the FDA issued a Complete Response Letter regarding its New Drug Application For LNTH-2501
Lantheus Holdings receives FDA Complete Response Letter for LNTH-2501 due to manufacturing facility issues