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Lantheus Holdings, Inc. is a global pharmaceutical company dedicated to the development, manufacturing, and commercialization of advanced diagnostic and therapeutic agents. Their mission is to empower clinicians worldwide in the accurate diagnosis and effective treatment of a wide spectrum of conditions, particularly heart disease, various cancers, and other serious illnesses. Their current diagnostic portfolio features several key products: DEFINITY, a microbubble ultrasound contrast agent for cardiac evaluations; TechneLite, a technetium generator essential for nuclear medicine; Xenon-133…

Leading pharmaceutical executive brings over 4 decades of commercial, M&A, and governance leadership Leading pharmaceutical executive brings over 4 decades of commercial, M&A, and governance leadership

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.

The U.S. Food and Drug Administration declined to approve Lantheus Holdings' diagnostic imaging kit for types of cancer tumors, citing unresolved manufacturing-related conditions at a third-party facility, the company said on Friday.

BEDFORD, Mass., June 26, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs).

Lantheus Holdings, Inc. (LNTH) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript