Why was Truseltiq discontinued? A look into the FDA approval withdrawal
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2 min read
In May 2024, the FDA announced the final withdrawal of approval for Truseltiq (infigratinib), a targeted therapy for bile duct cancer, just three years after its accelerated approval. This decision was voluntary on the part of the drug's manufacturer and provides a compelling case study on the risks inherent in the accelerated approval pathway.
