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Aug 21, 2026
IceCure Medical's ProSense cryoablation system gains IRB approval for the ChoICE post-marketing study in low-risk breast cancer, with patient enrollment expected soon. Additionally, Thomas Hospital in Alabama becomes the first facility in the state to install ProSense, with procedures starting this month.
Jul 21, 2026
Roche's giredestrant plus palbociclib missed its primary endpoint in a phase 3 breast cancer trial. Numerical improvement was seen without statistical significance. Shares fell sharply; a second readout is due in 2027.
Mar 31, 2026
Ataraxis AI has launched Ataraxis Breast CTX, an AI test that predicts individualized chemotherapy benefit for breast cancer patients. The tool uses digital pathology and clinical data to estimate patient-level outcomes with and without chemotherapy, moving beyond population averages. The test has been validated across studies involving over 10,000 patients and is now available through CLIA-certified laboratories.
Feb 20, 2026
The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.
Feb 20, 2026
The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
