Clinical data demonstrated achievement of the primary pharmacokinetic endpoint, with urine output and sodium and potassium excretion comparable with those observed with intravenous furosemide, according to MannKind.
In a randomized crossover trial of insulin-treated patients receiving hemodialysis, real-time continuous glucose monitoring did not improve the primary hypoglycemia outcome but increased time in range and reduced time above range vs capillary testing.
Researchers reported that an artificial intelligence workflow maintained high interpretive accuracy while reducing urine drug test sign-out time in a supervised clinical laboratory setting.
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The approval was based on reduced proteinuria, and an ongoing trial is required to determine whether atacicept slows long-term kidney function decline.
The action relates to previously identified third-party manufacturing deficiencies rather than concerns about the clinical efficacy or safety data, according to the company.