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- FDA pauses Regenxbio gene therapy trial for Hunter syndrome after spinal masses foundThe Food and Drug Administration has placed another hold on Regenxbio's gene-therapy trial for mucopolysaccharidosis type II, also known as Hunter syndrome, after new safety concerns emerged. Five…
- FDA to Issue Formal Guidance on Regulating Generative AI Medical DevicesThe Food and Drug Administration announced that it is creating a plan to regulate medical devices that incorporate generative artificial intelligence. Rick Abramson, director of the agency’s Digita…