OS Therapies Inc. Schedules Key FDA Meeting for OST-HER2 Osteosarcoma Program, Advances Toward Global Regulatory Approvals

Reuters
2025/07/10
<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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. OS Therapies Inc. published the original content used to generate this news brief via Newsfile (Ref. ID: 258373) on July 10, 2025, and is solely responsible for the information contained therein.

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