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China's First Homegrown Radiopharmaceutical Receives Dual FDA Breakthrough Therapy and Fast Track Designations

On August 6, Nuoyu Medical announced that the U.S. Food and Drug Administration (FDA) has officially granted Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) to the company's independently developed 68Ga-NYM096. This marks the first product in China's original radiopharmaceutical field to receive FDA Breakthrough Therapy Designation, and the first to receive both FDA Breakthrough Therapy and Fast Track designations simultaneously, creating a milestone breakthrough in the radiopharmaceutical field. 68Ga-NYM096 is a small-molecule diagnostic radiopharmaceutical for renal cancer that specifically binds to CAIX, suitable for positron emission tomography (PET) imaging of suspected or confirmed metastatic clear cell renal cell carcinoma (c...

2026-08-08

US FDA Approves Pluvicto Expanded Indication for Treatment of PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

On July 31, 2026, Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer. This disease is commonly referred to as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on results from the Phase III PSMAddition trial. The study showed that compared with standard of care alone, namely ARPI combined with androgen deprivation therapy (ADT), Pluvicto plus standard of care reduced the risk of disease progression or death by...

2026-08-03