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Two anti-proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) monoclonal antibodies, Alirocumab and Evolocumab, have been approved for the treatment of hypercholesterolaemia in certain patients. ...


The European Commission has granted marketing authorization for Epclusa ( Sofosbuvir 400 mg / Velpatasvir 100 mg ), the first pan-genotypic, single tablet regimen for the treatment of adults with geno ...


The FDA ( Food and Drug Administration ) has granted a Breakthrough Therapy Designation to the immunotherapy Darzalex ( Daratumumab ) in combination with Lenalidomide ( Revlimid ), an immunomodulatory ...


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for the medicinal product Truberzi, intended for the treatment of adults with irritable bowel syndrome with d ...


The Committee for Medicinal Products for Human Use ( CHMP ), the scientific committee of the European Medicines Agency ( EMA ) has provided a positive opinion for Cabometyx ( Cabozantinib ) 20, 40, 6 ...


The European Commission ( EC ) has approved Keytruda ( Pembrolizumab ), the anti-PD-1 therapy, at a dose of 2 mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell l ...


The Food and Drug Administration ( FDA ) has approved Keytruda ( Pembrolizumab ), the anti-PD-1 ( programmed death receptor-1 ) therapy, at a fixed dose of 200 mg every three weeks, for the treatment ...


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 ...