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- FDA approves Isembyld, first therapy to target muscle loss in SMA patientsScholar Rock received FDA approval for Isembyld, the first drug designed to address muscle loss in spinal muscular atrophy (SMA). The approval covers adults and children aged two years and older w…
- FDA grants de novo clearance to Powerful Medical’s AI tool for detecting severe heart attacks on EKGsThe U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s AI algorithm that analyzes electrocardiograms to identify severe heart attacks. This clearance allows th…