OS Therapies Inc. Advances OST-HER2 with UK MHRA Positive Feedback and Submits ILAP Request for Osteosarcoma Treatment Approval
Reuters
Aug 07
<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Inc. Advances OST-HER2 with UK MHRA Positive Feedback and Submits ILAP Request for Osteosarcoma Treatment Approval
OS Therapies Inc. (NYSE American: OSTX), a clinical-stage immunotherapy and Antibody Drug Conjugate $(ADC)$ biopharmaceutical company, has announced progress in its regulatory approval process for OST-HER2, aimed at preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma. Following a successful Scientific Advice Meeting with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in July, the company has submitted an Innovative Licensing and Access Pathway (ILAP) application. Furthermore, MHRA has recommended OS Therapies to apply for Project Orbis to align its Marketing Authorization Application with the U.S. FDA's Biologics Licensing Application Accelerated Approval Program. The Netherlands Medicines Evaluation Board has also scheduled a Scientific Advice Meeting for October 2025, marking a significant step towards a European Union-wide Marketing Authorisation via the Centralised Procedure. OS Therapies is working diligently to ensure rapid approval of OST-HER2 to benefit metastatic osteosarcoma patients globally.
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