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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).
Oral medications in the same category tend to be less expensive than their injectable counterparts due in part to how they are manufactured, stored, and distributed, she explains
A more serious concern with long term GLP-1RA usage relates to the potential increased risk for PDAC due to promoting cellular proliferation
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