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.
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The FDA has approved a new indication for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease, doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and diabetic nephropathy with albuminuria >300mg/day.
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease (ESRD) and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
A recently published report describes the case of a 62-year-old patient who experienced rare but serious central nervous system (CNS) side effects following the initiation of gabapentin therapy.
The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication. Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It…
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.
Temixys combines lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), which are 2 nucleoside reverse transcriptase inhibitors.
The study, which was an open multi-cohort Markov model, aimed to analyze the clinical and economic outcomes of the United States HCV population from 2018 on.
Patients treated with JAK inhibitors for rheumatoid arthritis may be less likely to have low disease activity if they are obese compared with those who are overweight.