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The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending marketing authorisation in the European Union for the u ...


The U.S. Food and Drug Administration ( FDA ) has approved once-daily Yosprala, the only prescription fixed-dose combination of Aspirin, an anti-platelet agent, and Omeprazole, a proton pump inhibitor ...


The European Commission ( EC ) has issued a marketing authorisation for Kisplyx ( Lenvatinib ) in combination with Everolimus ( Afinitor ) for the treatment of adult patients with advanced renal cell ...


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 ...


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 ...



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