gents, the current standard of care. The investigational agent has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients aged 2 years and older with MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and the body. FDA Fast Track designation expedites the review of new therapeutics and medical imaging agents that have the potential to address significant unmet patient needs.

MRI contrast agents enhance the visualization of abnormal structures or lesions during imaging procedures and help clinicians better distinguish between healthy and diseased tissue. Mangaciclanol is intended for general-purpose MR imaging and demonstrates comparable relaxivity (the ability to enhance signal intensity) to market-leading gadolinium-based agent, gadobutrol, with early clinical images suggesting similar diagnostic capability. Unlike gadolinium, which is a rare-earth metal, manganese i
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