Bone fracture protein therapy gets US thumbs down
This article was originally published in Clinica
Wyeth-Ayerst Laboratories has failed to gain US marketing approval for its recombinant protein-based product for treating long-bone fractures. The FDA has issued the company with a "not-approvable" letter following concerns about the clinical study design and the interpretation of clinical data used to support the company's PMA application for the product.
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