08:35 AM EDT, 08/14/2026 (MT Newswires) -- Lantheus ( LNTH ) said Friday the US Food and Drug Administration approved Tauklarify, also known as MK-6240, for PET imaging of the brain in adults with cognitive impairment being evaluated for Alzheimer's disease.
The company said the radiodiagnostic agent helps identify patients with tau neurofibrillary tangle pathology.
Lantheus ( LNTH ) said its safety and effectiveness have not been established for evaluating non-Alzheimer's disease tauopathies.
The approval was supported by two blinded studies involving more than 500 subjects, the company said. adding that independent readers assessed Tauklarify PET scans for tau pathology, with positive agreement ranging from 68% to 82% and negative agreement from 93% to 99%.