In expanded research, investigators studied the effects of therapeutic and prophylactic anticoagulation treatment in hospitalized patients with COVID-19.
Inadvertent administration may result in serious adverse events.
The Agency requested that the Company provide substantial evidence from its phase 3 study demonstrating durable effect using annualized bleeding rate.
Xyntha works by temporarily replacing the missing clotting factor VIII that is needed for effective hemostasis.
One nonfatal adverse event has been reported during the timeframe the affected product was distributed.
Caplacizumab appears to be safe and effective among patients with acquired thrombotic thrombocytopenic purpura treated in the real-world setting.
Sustained improvement was noted after the administration of tocilizumab, an interleukin-6 antagonist.
The FDA has approved Sevenfact (coagulation factor VIIa [recombinant]-jncw; LFB Biotechnologies) for the treatment and control of bleeding episodes occurring in patients aged ≥12 years with hemophilia A or B with inhibitors.
Dr. Reddy’s Laboratories announced the voluntary recall of 4 lots of Phytonadione Injectable Emulsion 10mg/mL single-dose ampules to the hospital level due to ampules breaking and shattering, upon opening, during compounding.
The Agency also accepted the premarket approval (PMA) application for an AAV5 total antibody assay, a companion diagnostic test for valoctocogene roxaparvovec.
