OS Therapies initiates US FDA BLA filing for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

OS Therapies

2 February 2026 - OS Therapies today announced that it has formally initiated a biologics license application submission to the US FDA for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. 

The Company has submitted the non-clinical and the chemistry, manufacturing and controls modules of the biologics license application to FDA, along with a request for rolling review.

Read OS Therapies press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier , Registration