Lantheus Holdings, Inc.
0 products tracked · names used in filings: Lantheus Holdings, Inc.
Upcoming milestones
No upcoming milestones listed.
Recent milestones
MK-6240: PDUFA target action date (tau-targeted PET imaging for Alzheimer's disease diagnostics)
Lantheus Holdings, Inc. (LNTH); NDA; status: set; "The FDA has set a PDUFA target action date of August 13, 2026."; filed 2025-11-06 · source
LNTH-2501: PDUFA target action date (PET diagnostic imaging of somatostatin receptor-positive neuroendocrine tumors (NETs))
Lantheus Holdings, Inc. (LNTH); Ga 68 edotreotide; status: extended; "…The FDA extended the PDUFA date for LNTH‑2501(Ga 68 edotreotide), the Company’s PET diagnostic imaging kit for somatostatin receptor‑positive neuroendocrine tumors (NETs), by three months to June 29, 2026, to allow additional time to review manufacturing‑related information."; filed 2026-05-07 · source
new formulation of piflufolastat F 18 (PYLARIFY): PDUFA target action date (PSMA PET imaging for prostate cancer)
Lantheus Holdings, Inc. (LNTH); piflufolastat F 18; NDA; status: set; "The FDA has set a PDUFA target action date of March 6, 2026."; filed 2025-11-06 · source
piflufolastat F 18 new formulation: PDUFA target action date (PSMA PET imaging)
Lantheus Holdings, Inc. (LNTH); piflufolastat F 18; NDA; status: set; "…Announced FDA acceptance of NDA for new formulation for piflufolastat F 18 PSMA PET imaging agent with a PDUFA date of March 6, 2026 • Closed acquisition of Life Molecular Imaging in July, immediately expanding near- and long-term growth profile and co"; filed 2025-08-06 · source
PYLARIFY new formulation (F 18 PSMA imaging agent): PDUFA target action date (PSMA PET imaging in prostate cancer)
Lantheus Holdings, Inc. (LNTH); piflufolastat F 18; NDA; status: set; "Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent Designed to expand PSMA PET imaging access for patients by increasing batch size by ~50% and enhancing supply resilience PDUFA date set for March 6, 2026"; filed 2025-08-06 · source
Products
No products recorded.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.