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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 signals upcoming rules for generative AI use in drug developmentThe FDA announced it intends to create regulatory guidance for the use of generative artificial intelligence in pharmaceutical research and development. The move follows growing interest in AI too…