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Vemlidy Labeling Updated With Dosing Info for Patients With ESRD

The Food and Drug Administration (FDA) has approved a labeling update for Vemlidy (tenofovir alafenamide; Gilead Sciences) to include dosage information regarding its use in adults with end-stage renal disease (ESRD; CrCl <15mL/min) who are receiving chronic hemodialysis.
Drugs in the Pipeline

Phase 3 Long-Term Study of Zerenex for Hyperphosphatemia in ESRD

Keryx Biopharmaceuticals announced top-line results from the long-term Phase 3 study of Zerenex (ferric citrate), for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.
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Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies

The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.