Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...

The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 ...

The US Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Alzheimer’s disease (AD) blood test to help ...

The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that ...

The FDA has approved the first blood test for diagnosing Alzheimer’s disease, which could speed the path to treatment for ...

Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the ...

The Food and Drug Administration (FDA) announced Friday it had cleared a new test to help diagnose adults with Alzheimer’s ...

The approval comes as two Alzheimer's drugs—lecanemab and donanemab—are already authorized by the FDA. Both are antibody therapies that target amyloid plaques and are believed to be more effective ...

Not all people should take Fujirebio's new test. The FDA says that it is "intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline" and is ...

The FDA cleared the first blood test on Friday to help diagnose Alzheimer's disease among older Americans already exhibiting ...

The FDA has cleared the first blood test to diagnose Alzheimer's which works by measuring the amount of pTau 217 and ...