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Since launching its rolling BLA submission in December under an Accelerated Approval pathway, Sangamo has submitted preclinical and clinical modules, as well as submitted its antibody assay companion diagnostic, designed to screen patients for eligibility with isaralgagene civaparvovec, to the FDAs Center for Devices and Radiological Health (CDRH), seeking Premarket Approval (PMA).

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, Andrew Bremer , Julia Belluz , Kirsten Bibbins-Domingo , Lehana Thabane, PhD , Arthur Lupia , Rachel Batterham OBE , Mads Hjorth , Mads Krogsgaard Thomsen , Jens Lund , Berit L Heitmann , susan hilsenbeck , Salma Musaad, MD, PhD , Sanjay Shete , Steven N

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