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BioWorld - Tuesday, June 30, 2026
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Home » Bridgebio wins accelerated approval for cholangiocarcinoma therapy
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Bridgebio wins accelerated approval for cholangiocarcinoma therapy

May 28, 2021
By Michael Fitzhugh
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
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