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.
A review of 56 qualitative studies found residents' emotional experiences were influenced by interactions among training demands, workplace relationships, and their evolving professional identity.
A structured overview of recent FDA recalls, corrections, and alerts involving medications, ventilators, insulin delivery systems, cardiovascular devices, anesthesia products, and other equipment used in clinical practice.
“High-dose intravenous vitamin C administered early after injury did not reduce organ dysfunction or [mortality] and should not be a treatment in severe burns.”