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
BEDFORD, Mass., June 03, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company dedicated to helping clinicians Find, Fight, and Follow disease to deliver better patient outcomes, today announced John Wiggins, Vice President, External Manufacturing, will participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference at 8:40 a.m.
BEDFORD, Mass., June 02, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. ("Lantheus") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that an image generated using LNTH-2513 (18F-GP1) PET/CT was awarded SNMMI's Image of the Year at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting in Los Angeles, California. The recognition was presented in connection with investigator-initiated trial results evaluating LNTH-2513 PET/CT for the detection of acute lower-extremity deep vein thrombosis (DVT) in symptomatic patients.
BEDFORD, Mass., May 27, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company dedicated to helping clinicians Find, Fight, and Follow disease to deliver better patient outcomes, today announced John Wiggins, Vice President, External Manufacturing, will participate in a fireside chat at the William Blair 46th Annual Growth Stock Conference at 12:10 p.m. ET on Wednesday, June 3.
Lantheus Holdings is weighing a potential sale after getting a takeover offer from private-equity backed Curium Pharma that could value it at about $7 billion, Bloomberg News reported on Friday, citing people familiar with the matter.
BEDFORD, Mass., May 21, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced new radiodiagnostic data to be presented at the 2026 Society of Nuclear Medicine and Medical Imaging (SNMMI) Annual Meeting, taking place May 30 – June 2, 2026 in Los Angeles, CA.
BEDFORD, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced data to be featured at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026 in Chicago, IL.
