Clinical Trials - May 5, 2015
Transplant Drug Shows Promise
Veloxis Pharmaceuticals’ once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower, once-a-day dose of Envarsus XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus. The […]
Drug Development Pharma - April 22, 2015
More Good News for Kidney Transplant Drug
Trials of once-daily Envarsus® XR, an investigational drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose in African-American patients is sufficient for therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus, according to Veloxis. Veloxis is seeking an order requiring the FDA to […]
Companies - December 18, 2014
Veloxis Files Suit Against FDA
Denmark’s Veloxis Pharmaceuticals A/S announced that it has filed an action in federal district court for the District of Columbia against the U.S. Food and Drug Administration, seeking an order requiring the FDA to grant final approval to Envarsus® XR. Envarsus XR is a once-daily extended-release tablet indicated for prophylaxis of organ rejection in kidney […]
