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COMPASS Trial Ending Early After Reaching Superiority Endpoint

Janssen announced that the Phase 3 trial, COMPASS, is stopping earlier than planned based on the recommendation of the study's Independent Data Monitoring Committee (DMC), as the primary major adverse cardiovascular events (MACE) endpoint has reached its pre-specified criteria for superiority.

ASH: Benefits of Xarelto in Cancer-Associated Thrombosis Presented

At the 2016 American Society of Hematology (ASH) Annual Meeting, researchers from Janssen and Bayer presented data showing that cancer patients treated with Xarelto (rivaroxaban) for blood clots had significantly fewer emergency room (ER) visits and lower healthcare costs at start of therapy vs. patients given standard treatment.

Xarelto Efficacy Supported by New Real-World Data

Janssen and Bayer announced new data from two real-world studies that confirmed the positive benefit-risk profile of Xarelto (rivaroxaban) for the treatment of venous thromboembolism (VTE) and reducing the risk of recurrence.

Factor Xa Inhibitor Bleeding Halts with Andexanet Bolus Infusion

For acute major bleeding within 18 hours after factor Xa inhibitor administration, a bolus and infusion of andexanet alfa (andexanet) reduces factor Xa activity, according to a study published online in the New England Journal of Medicine. The research was published to coincide with the annual European Society of Cardiology Congress.
Drug Monograph Updates

August 2016 Recap of Drug Updates

The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of August. The chart below provides highlights of key monograph updates made this month (not an inclusive list). Click on the name of the drugs to view the full monographs on Key: D=Dosing,…
Drugs in the Pipeline

FDA Wants More Data for Anticoagulant Antidote AndexXa

The FDA has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) of AndexXa (andexanet alfa; Portola) as a reversal agent for life-threatening or uncontrolled bleeding due to Factor Xa inhibitors.

Bleeding Rates High After Dual Antiplatelet Therapy, Post-PCI

For patients with atrial fibrillation at moderate to high risk of stroke, dual antiplatelet therapy (DAPT) use is variable among those undergoing percutaneous coronary intervention (PCI), according to a study published in JACC: Cardiovascular Interventions.