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Roche has announced that the European Medicines Agency ( EMA ) has validated the company’s Marketing Authorisation Application ( MAA ) of Ocrevus ( Ocrelizumab ) for the treatment of relapsing multipl ...


The FDA ( Food and Drug Administration ) Advisory Committee has voted 12-11 that substantial evidence exists to establish that Jardiance ( Empagliflozin ) reduces cardiovascular death in adults with t ...


The FDA ( Food and Drug Administration ) has approved Zinbryta ( Daclizumab ) for the treatment of adults with relapsing forms of multiple sclerosis. Zinbryta is a long-acting injection that is self- ...


The Antimicrobial Drugs Advisory Committee of the FDA ( Food and Drug Administration ) has discussed Zinplava ( Bezlotoxumab ), an investigational agent for prevention of Clostridium difficile ( C. d ...


The Committee of Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of a variation to the marketing authorization o ...


The FDA ( Food and Drug Administration ) has approved Cabometyx ( Cabozantinib ) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The ...


The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has granted a positive opinion for Humira ( Adalimumab ) for the treatment of non-infectious interm ...


The FDA ( U.S. Food and Drug Administration ) has granted Orphan Drug Designation for MYK-461 for treatment of symptomatic obstructive hypertrophic cardiomyopathy ( oHCM ), a subset of hypertrophic ca ...


The FDA ( Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class ( ...


The U.S. Food and Drug Administration ( FDA ) has approved an additional indication for Lenvima ( Lenvatinib mesylate ) in combination with Everolimus ( Afinitor ) for the treatment of patients with a ...


The European Commission ( EC ) has approved Alprolix ( rFIXFc ) for the treatment of haemophilia B in all 28 European Union ( EU ) member states and maintained its orphan designation. Alprolix is th ...


The European Commission has approved Empliciti ( Elotuzumab ) for the treatment of multiple myeloma as combination therapy with Revlimid ( Lenalidomide ) and Dexamethasone in patients who have receive ...


The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion, recommending broadening the existing marketing authorisation for Im ...


The Committee for Medicinal Products for Human Use ( CHMP ) of European Medicine Agency ( EMA ) has adopted a positive opinion for Gazyvaro ( Obinutuzumab; Gazyva in U.S. ) in combination with Bendam ...


The fixed-dose combination of Sacubitril and Valsartan ( Entresto ) has been approved for adults with symptomatic chronic heart failure with reduced ejection fraction. The German Institute for Quali ...