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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,…
- FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in JapanThe U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…