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FDAs Oncologic Drugs Advisory Committee votes nine to one in favor of approving a Mesoblast BLA for Ryoncil (remestemcell-L) as a ...[ Price : $8.95]
Federal Register notice: FDA proposes to reclassify non-invasive bone growth stimulators from postamendments Class 3 devices into ...[ Price : $8.95]
CBERs Office of Compliance and Biologics Quality sends East West Health Solutions (Lake City, UT) an untitled letter based on a re...[ Price : $8.95]
FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controlle...[ Price : $8.95]
Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug pro...[ Price : $8.95]
FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.[ Price : $8.95]
FDA releases a draft guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.[ Price : $8.95]
FDA approves the expanded use of Amarins Vascepas (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to s...