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- FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detectedThe FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…
- Roche and Eli Lilly receive FDA clearance for first blood test detecting Alzheimer’s biomarker pTau217Roche and Eli Lilly have secured FDA clearance for a new blood test that measures phosphorylated tau protein pTau217, a marker linked to amyloid plaques in Alzheimer’s disease. The Elecsys pTau217…