MHRA to lead global regulatory review of OS Therapies' OST-HER2

  • OS Therapies said the MHRA will lead OST-HER2's global regulatory review under Project Orbis.
  • OS Therapies said MHRA alignment enables an upcoming regulatory submission for OST-HER2.
  • OS Therapies completed an FDA Type C meeting on OST-HER2 statistical methods.

OS Therapies said the UK Medicines and Healthcare products Regulatory Agency (MHRA) will lead the global regulatory review of its OST-HER2 cancer immunotherapy under Project Orbis. The company also completed a U.S. Food and Drug Administration (FDA) Type C meeting focused on statistical methods for OST-HER2. MHRA alignment supports an upcoming regulatory submission, although the announcement excerpt does not identify its specific type.

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