Lower extremity revascularization (LER), a surgical procedure that can restore blood flow to blocked arteries in the legs, is often necessary for people with peripheral artery disease (PAD). While it ...
The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary ...
Johnson & Johnson and Bayer's legacy blood thinner Xarelto has had a tough year with competitors picking up steam and prescriptions leveling off. But in a hard-to-treat artery disease, the drug just ...
RARITAN, N.J. — The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.
RARITAN, N.J., July 8, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new results from the Phase 3 EINSTEIN-Jr study, showing pediatric patients (aged ...
Landmark Phase III Study of Bayer's Xarelto® (Rivaroxaban) Initiated for the Secondary Prevention of Myocardial Infarction and Death in Patients with Coronary or Peripheral Artery Disease ...
FRANKFURT (Reuters) - Bayer said its development partner Johnson & Johnson filed a response to U.S. regulators' concerns over a new use for their Xarelto anti-clotting pill to prevent heart attacks ...
Janssen Research & Development announced that the FDA has assigned a Priority Review designation to its supplemental New Drug Application (sNDA) filed for Xarelto (rivaroxaban) to reduce the risk of ...
Xarelto® is marketed for VTE prevention in adult patients following elective hip or knee replacement surgery, and it is the only oral anticoagulant that has consistently demonstrated superior efficacy ...
First approval for Bayer's new oral, once-daily anticoagulant / Marketing to start immediately / First-in-class product to demonstrate superior efficacy to standard of care / Most studied oral, direct ...