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Janssen gets FDA’s green light for Xarelto for prevention of blood clots

The U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding, Janssen said Monday in a press release.

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JJ gets FDA’s approval of Invokana to treat diabetic kidney

FDA has approved Invokana (canagliflozin) to treat diabetic kidney disease (DKD) and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes (T2D) and DKD, which is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKD.

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Janssen files for sBLA to FDA for Tremfya

The Janssen has filed for a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of guselkumab brand Tremfya, for the treatment of adult patients with active psoriatic arthritis (PsA), and expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.

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