The approval was based on data from a phase 3 study which included adults with steroid-resistant active PMR who flared on at least 7.5mg per day of prednisone or equivalent during taper.
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In patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45%.
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
MK-2060 is an investigational monoclonal antibody designed to inhibit the activation of Factor XI and its ability to activate downstream proteins.
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
The prescribing information for Lokelma® (sodium zirconium cyclosilicate; AstraZeneca) has been updated to include a dosing regimen to treat hyperkalemia in patients with end-stage renal disease (ESRD) on chronic hemodialysis.
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.