The FDA has approved an oral tablet formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) for chronic weight management in adults. It is the first oral GLP-1 receptor agonist to be approved in the US for weight management. An injectable formulation of Wegovy was approved for the same indication in 2021.1 The injectable GLP-1 receptor agonist liraglutide (Saxenda, and generic) and the injectable glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Zepbound) are also FDA-approved for chronic weight management (see
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ISSUE
Elecsys Phospho-Tau (181P) Plasma (Roche), a blood-based diagnostic test, has been cleared by the FDA to aid in the initial assessment of amyloid plaque pathology associated with Alzheimer's disease (AD) in patients ≥55 years old with signs of cognitive decline. It is the second blood test for AD biomarkers to be cleared by the FDA; the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test was cleared in 2025 (see Table 1).1
BIOMARKERS IN AD ― Detection of molecular biomarkers in blood (e.g., amyloid beta, phosphorylated Tau [pTau]) has been shown to correlate with the presence of amyloid pathology in the brain. Standard tests for detection of brain amyloid pathology include amyloid PET scans and CSF biomarker testing.2,3 Confirmation of brain amyloid beta deposition is required prior to use of the amyloid beta-directed monoclonal antibodies lecanemab …