FDA Denies Approval of Roxadustat for Anemia in CKD
The FDA noted that the application could not be approved in its present form and had requested an additional clinical study be conducted.
Diagnosis & Disease Information
Kerendia Approved to Reduce CKD Progression, CV Risk in Patients With Diabetic Kidney Disease
The approval was based on data from the phase 3 FIDELIO-DKD trial.
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