U.S. FDA declines to approve FibroGen’s anemia drug citing insufficient trial data

USA – FibroGen Inc said has announced that the U.S. Food and Drug Administration has declined to approve its treatment for anemia of chronic kidney disease, citing the need for an additional clinical study. Last month, a panel of experts to the FDA voted against the approval of the company’s drug candidate, roxadustat, which the company is developing in partnership with AstraZeneca. FibroGen shares slipped 2.5% to $12.9 before the bell following the negative decision by the regulator. Ahead of the expert panel meeting, the FDA had raised concerns about…

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