Analysis of FDA-approved imaging agents

Abstract

The development of imaging agents was initially driven following the discovery of X-ray technologies, but quickly evolved and expanded to include radiolabeling of cells and tissues to assist disease diagnosis and progression. The first imaging agents preceded the Great War but the field did not gain momentum until the 1950s. The approval rate for imaging NMEs continued at a high level for the remainder of the 20th century, but substantially decreased thereafter. This decline in approval rates corresponds with industry consolidation. Such losses have stabilized, but could have important implications for a field that has conveyed direct benefits to medicine and that could ensure the future of the wider biopharmaceutical industry.