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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 ...


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 ...


The FDA ( Food and Drug Administration ) has approved Idelvion, coagulation factor IX ( recombinant ), albumin fusion protein, for use in children and adults with hemophilia B. Idelvion is the first ...


The FDA ( Food and Drug Administration ) has granted Priority Review for Atezolizumab ( anti-PD-L1; MPDL3280A ) for the treatment of people with locally advanced or metastatic urothelial carcinoma ( m ...


The FDA ( Food and Drug Administration ) has approved Imbruvica ( Ibrutinib ) as a first-line treatment for patients with chronic lymphocytic leukemia ( CLL ). The approval is based on data from the ...


The FDA ( Food and Drug Administration ) has approved Briviact ( Brivaracetam ) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epil ...


The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy designation to PKC412 ( Midostaurin ). Midostaurin is an investigational treatment for adults with newly-diagnosed acute mye ...


The FDA ( Food and Drug Administration ) has approved additional indications for Harvoni ( Ledipasvir / Sofosbuvir ) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in c ...


The European Commission ( EC ) has approved Briviact ( Brivaracetam ) as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization ( spreading to both s ...


The phase 3 GAUSS-3 ( Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 ) trial evaluating Evolocumab ( Repatha ) in patients with high cholesterol who cannot tol ...


The FDA ( Food and Drug Administration ) has accepted the New Drug Application ( NDA ) and granted Priority Review for Venetoclax for the treatment of people with chronic lymphocytic leukemia ( CLL ) ...


The FDA ( Food and Drug Administration ) has granted accelerated approval for Darzalex ( Daratumumab ) to treat patients with multiple myeloma who have received at least three prior treatments. Darz ...


The FDA ( Food and Drug Administration ) has granted approval for Ninlaro ( Ixazomib ) in combination with two other therapies to treat people with multiple myeloma who have received at least one prio ...


Evolocumab ( Repatha ) is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) that is administered subcutaneously at a dosage of 140 mg every 2 weeks or 420 mg once ...


The FDA ( Food and Drug Administration ) has granted approval for Empliciti ( Elotuzumab ) in combination with two other therapies to treat people with multiple myeloma who have received one to three ...


The FDA ( U.S. Food and Drug Administration ) has approved Vistogard ( Uridine triacetate ) for the emergency treatment of adults and children who receive an overdose of the cancer treatment Fluoroura ...


The FDA ( Food and Drug Administration ) has approved Vonvendi, von Willebrand factor ( recombinant ), for use in adults 18 years of age and older who have von Willebrand disease ( VWD ). Vonvendi i ...


The European Commission has approved Cotellic ( Cobimetinib ) for use in combination with Zelboraf ( Vemurafenib ) for the treatment of adult patients with unresectable or metastatic melanoma with a B ...


The FDA ( Food and Drug Administration ) has approved a new second-generation lung cancer treatment that can help many patients in their battle against the disease. Lung cancer patients got another ro ...


Flomax Relief ( Tamsulosin ) is an alpha1-adrenoceptor antagonist, indicated for the treatment of functional symptoms of benign prostatic hyperplasia ( BPH ) in male 45 to 75 years. Tamsulosin bind ...


2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis – An Update of the 2011 Guideline suggests that clinicians use Ofev ( Nintedanib ) in patients with idiopa ...


Patients receiving Dimethyl fumarate ( DMF ) are at risk for opportunistic infections even without severe lymphocytopenia. An additional patient with progressive multifocal leukoencephalopathy ( PM ...


The European Commission has approved Humira ( Adalimumab ) for the treatment of active moderate to severe hidradenitis suppurativa ( acne inverse ) in adults with an inadequate response to convention ...


Nonsteroidal anti-inflammatory drugs ( NSAIDs ) have been assigned a promising role in the chemoprevention of various malignancies. However, epidemiological data on the association between NSAID use a ...


The European Medicines Agency ( EMA ) has recommended granting a marketing authorisation for Kanuma ( Sebelipase alfa ), for the treatment of lysosomal acid lipase ( LAL ) deficiency, a rare lifethrea ...


The European Medicines Agency ( EMA ) has recommended granting a marketing authorisation under exceptional circumstances for Strensiq ( Asfotase alfa ), for the long-term treatment of hypophosphatasia ...


The European Commission ( EC ) has approved Revolade ( Eltrombopag ) for the treatment of adult patients with severe aplastic anemia ( SAA ) who have had an insufficient response to immunosuppressive ...


The European Commission ( UE ) has approved Imbruvica ( Ibrutinib ) for the treatment of adult patients with Waldenström’s macroglobulinemia ( WM ) who have received at least one prior therapy, or in ...


Merck, known as MSD outside the United States and Canada, issued the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food ...


The FDA ( U.S. Food and Drug Administration ) has approved Alecensa ( Alectinib ) to treat people with advanced ( metastatic ) ALK-positive non-small cell lung cancer ( NSCLC ) whose disease has worse ...


Researchers in Denmark have found that negative news stories about statins are linked to some people choosing to discontinue their statin treatment, which, in consequence, is associated with an increa ...


The FDA ( Food and Drug Administration ) has approved Genvoya ( a fixed-dose combination tablet containing Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide ) as a complete regimen fo ...



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