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Apr 30, 2026
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
Mar 20, 2026
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
Mar 09, 2026
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
Mar 09, 2026
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
Mar 09, 2026
FDA elevated OS Therapies' Type D meeting to Type B pre-BLA meeting for OST-HER2 in osteosarcoma, signaling transition to Accelerated Approval discussions. Clinical data submission targeted for end of Q1 2026.
