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Norroy Bioscience's 68Ga-NYM096 Receives FDA Breakthrough Therapy and Fast Track Designations

Norroy Bioscience's 68Ga-NYM096 Receives FDA Breakthrough Therapy and Fast Track Designations

China-based Norroy Bioscience announced on August 19 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designations to its radiopharmaceutical imaging agent 68Ga-NYM096. The agent is a PET imaging tracer targeting carbonic anhydrase IX (CAIX), intended for imaging clear cell renal cell carcinoma (ccRCC). According to the company, 68Ga-NYM096 is being developed as a non-invasive PET imaging tool to characterize renal masses detected by CT or MRI and to help distinguish clear cell renal cell carcinoma from other non-ccRCC renal lesions. Clear cell renal cell carcinoma is the most common subtype of renal cell carcinoma...

2026-08-21

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