FDA Manufacturing Issues Delay Lantheus' Tumor Imaging Kit
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