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- Spruce Biosciences advances toward Q4 FDA filing for ultra-rare Sanfilippo B therapySpruce Biosciences reported progress toward filing its enzyme replacement therapy, tralesinidase alfa (TA-ERT), for Sanfilippo syndrome type B, an ultra-rare lysosomal disorder. The company said t…
- 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…