The GALILEO trial has been halted after an early peek at the data showed that rivaroxaban (Xarelto; Bayer/Janssen) was associated with greater risks of all-cause mortality, thromboembolic events, and ...

New questions are being raised about the clinical trial of a widely used heart drug, and critics are calling for an independent investigation, after a medical device used during the study was later ...

The FDA approved the first generics of the direct oral anticoagulant rivaroxaban, the agency announced on Tuesday. Rivaroxaban 2.5 mg tablets from Lupin and Taro are now considered therapeutic ...

Perugia, Italy - Promising phase 2 results with the new oral direct factor Xa inhibitor anticoagulant rivaroxaban (Bayer) in the treatment of patients with deep vein thrombosis (DVT) have been ...

BOSTON, MA—For patients undergoing transradial coronary procedures, a short course of rivaroxaban (Xarelto; Bayer/Janssen) reduces the rate of radial artery occlusion without significantly increasing ...

The NDA submission is supported by data from the phase 3 EINSTEIN-Jr and UNIVERSE trials in pediatric patients, along with adequate and well-controlled studies in adults. A New Drug Application (NDA) ...

In the COMPASS trial of patients with stable coronary or peripheral artery disease (PAD), the combination of aspirin plus rivaroxaban, 2.5 mg twice daily, provided a larger absolute benefit on ...

Although rivaroxaban was approved by the FDA in 2012, there has remained a knowledge gap about how it works with cancer patients. A recent study found that the therapy is safe and effective when used ...

Significantly lower risk for clinically relevant bleeding seen with apixaban than rivaroxaban during 3-month trial period. HealthDay News — The risk for clinically relevant bleeding is significantly ...

The Appraisal Committee considered evidence submitted by the manufacturer of rivaroxaban and a review of this submission by the Evidence Review Group (ERG). The manufacturer's submission compared ...

The appraisal committee considered evidence submitted by Bayer, a review of this submission by the evidence review group (ERG), and the technical report developed through engagement with stakeholders.