OS Therapies Inc. Schedules Key FDA Meeting for OST-HER2 Osteosarcoma Program, Advances Toward Global Regulatory Approvals
Reuters
Jul 10
<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Inc. Schedules Key FDA Meeting for OST-HER2 Osteosarcoma Program, Advances Toward Global Regulatory Approvals
OS Therapies Inc., a clinical-stage biopharmaceutical company, has announced significant progress in its regulatory review efforts for OST-HER2, a treatment targeting recurrent, pulmonary metastatic osteosarcoma. The company is set to meet with the US Food & Drug Administration (FDA) on August 27, 2025, to discuss the clinical data from its Phase 2 program and seek alignment for a rolling review Biologics Licensing Application under the FDA's Accelerated Approval Program. Additionally, OS Therapies has scheduled Scientific Advice Meetings with global regulators, including the European Medicines Agency, as part of its strategy to obtain a Centralized Marketing Authorization in the EU and a Conditional Marketing Authorization in the UK. These steps are crucial for advancing OST-HER2 towards regulatory approval and potential commercialization.
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