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NORROY BIOSCIENCE Receives FDA Breakthrough Therapy and Fast Track Designations for 68Ga-NYM096 in Kidney Cancer Imaging

Shots: NORROY BIOSCIENCE reported that the FDA has granted Breakthrough Therapy and FTD to 68Ga-NYM096, a radiopharmaceutical imaging agent targeting CAIX for PET imaging of clear cell renal cell carcinoma (ccRCC) 68Ga-NYM096 is being developed as a non-invasive PET imaging agent to characterize indeterminate renal masses identified by CT or MRI and help differentiate ccRCC…

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Telix Pharmaceuticals

Telix Reports the First Patient Dosing in P-III (LUTEON) Trial of TLX250-Tx for Renal Cancer

Shots: Telix has dosed the first patient with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the P-III (LUTEON) study to identify eligible pts with CAIX-positive tumors in r/r clear cell renal cell carcinoma (ccRCC) LUTEON trial in Australia is part of Telix’s global development program for TLX250-Tx, alongside the P-IIa (LUTEON ATLAS) study in the US…

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Merck new

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…

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