DrugsNews.net

Drugs Xagena

The FDA ( Food and Drug Administration ) has approved Praluent ( Alirocumab ) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtil ...


The FDA ( Food and Drug Administration ) has approved Iressa ( Gefitinib ) for the first-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) whose tumors harbor specific ty ...


The FDA ( Food and Drug Administration ) has approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation. Orkambi ...


Opdivo, a PD-1 checkpoint inhibitor approved in Europe, for both first-line and previously-treated advanced melanoma patients The European Commission has approved Opdivo ( Nivolumab ), a PD-1 immu ...


The FDA ( Food and Drug Administration ) has approved Entresto ( Sacubitril / Valsartan ) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death ...


The FDA ( Food and Drug Administration ) has approved Kengreal ( Cangrelor ), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries. It is approved ...


Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) adopted a positive opinion for a Type-II Variation related to the update of the European summary of the ...


The ASCO Task Force has applied the Framework to four clinical scenarios in which multiple trials have compared new treatment options with current standards of care: first-line treatment for metastati ...


The European Commission has granted marketing authorization in Europe for Toujeo ( Insulin glargine [ rDNA origin ] injection, 300 U/mL ), a next-generation basal Insulin for the treatment of type 1 a ...


Following premature disclosure of interim study results, the 9,000-patient Light Trial, designed to study the cardiovascular safety of the obesity drug Contrave ( Buproprion and Naltrexone ), has been ...


Roflumilast ( Daxas; Daliresp ), a drug approved to treat severe chronic obstructive pulmonary disease ( COPD ), increases the production of a protein that causes inflammation, which possibly results ...


The European Committee for Medicinal Products for Human Use ( CHMP ) has recommended approval of Lixiana ( Edoxaban ), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke a ...


Lomitapide ( Lojuxta [ EU ], Juxtapid [ US ] ) lowers cholesterol through a different pathway, i.e. through the inhibition of the microsomal triglyceride transfer protein ( MTP ). MTP is involved in ...


Warfarin ( Coumadin ) is the most widely used oral anticoagulant worldwide, but serious bleeding complications are common. Researchers have tested whether genetic variants can identify patients who ...


The European Union ( EU ) Commission has approved Xiapex ( Collagenase clostridium histolyticum ) for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity ...


The FDA ( Food and Drug Administration ) has approved Opdivo ( Nivolumab ) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer ( NSCLC ) w ...


The European Commission ( EU ) has approved a variation to the terms of the marketing authorisation of Velcade ( Bortezomib ) in combination with Rituximab, Cyclophosphamide, Doxorubicin and Prednison ...


A multicenter, randomized, double-blind, placebo-controlled, active-referenced ( Duloxetine 60 mg ), parallel-group study evaluated the short-term efficacy and safety of Vortioxetine ( 10-20 mg ) [ Br ...


The European Commission ( EC ) has approved Revlimid ( Lenalidomide ) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The Revlimi ...


The European Commission has approved the use of Xadago ( Safinamide ) for the treatment of idiopathic Parkinson’s disease. Xadago has been approved for mid-to late-stage fluctuating patients as add- ...


The FDA ( Food and Drug Administration ) has granted approval to Lenvima ( Lenvatinib ) to treat patients with progressive, differentiated thyroid cancer ( DTC ) whose disease progressed despite recei ...


The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) issued positive opinions recommending marketing authorization for three of its pipeline development ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Ibrance ( Palbociclib ) to treat advanced ( metastatic ) breast cancer. Breast cancer in women is the second most common ...


The European Medicines Agency's ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for Abraxane ( Paclitaxel formulated as albumin-bound nanoparticles, or N ...


The European Commission ( EC ) has granted marketing authorisation for Otezla ( Apremilast ), an oral selective inhibitor of phosphodiesterase 4 ( PDE4 ), in two therapeutic indications: A) For the t ...


The European Commission ( EC ) has approved Cosentyx ( Secukinumab ) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. Cos ...


< br>The European Commission ( EC ) has granted marketing authorizations for Abbvie's all-oral, short-course, Interferon-free treatment of Viekirax ( Ombitasvir / Paritaprevir / Ritonavir tablet ...


The FDA ( Food and Drug Administration ) has approved the anti-clotting drug Savaysa ( Edoxaban tablets ) to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation that i ...


Many patients treated with statins are considered statin-resistant because they fail to achieve adequate reduction of low density lipoprotein cholesterol ( LDL-C ) levels. Some patients are statin-i ...


The FDA ( Food and Drug Administration ) has approved Saxenda ( Liraglutide [ rDNA origin ] injection ) as a treatment option for chronic weight management in addition to a reduced-calorie diet and ph ...


The FDA ( Food and Drug Administration ) has approved Xtoro ( Finafloxacin otic suspension ), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Acute otitis externa is ...


The FDA ( Food and Drug Administration ) has granted accelerated approval for Blincyto ( Blinatumomab ) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor ac ...


Duaklir Genuair ( Aclidinium bromide / Formoterol fumarate 340/12 mcg ) has been granted marketing authorisation by the European Commission ( EC ) to be used as a maintenance bronchodilator treatment ...


The European Commission has granted EU marketing authorisation for Vargatef ( Nintedanib ). Vargatef in combination with Docetaxel ( Taxotere ) is indicated for use in adult patients with locally adva ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Lynparza ( Olaparib ), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Opdivo ( Nivolumab ), a new treatment for patients with unresectable ( cannot be removed by surgery ) or metastatic ( advan ...


The European Commission ( EC ) has approved Cometriq ( Cabozantinib ) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma ( MT ...


The FDA ( Food and Drug Administration ) has approved Viekira Pak ( Ombitasvir, Paritaprevir and Ritonavir tablets co-packaged with Dasabuvir tablets ) to treat patients with chronic hepatitis C virus ...


The FDA ( Food and Drug Administration ) has approved Hysingla ER ( Hydrocodone bitartrate ), an extended-release ( ER ) opioid analgesic to treat pain severe enough to require daily, around-the-clock ...


The European Commission has granted marketing authorization for Harvoni ( Ledipasvir 90 mg / Sofosbuvir 400 mg ), the first once-daily single tablet regimen to treat the majority of chronic hepatitis ...


The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy Designation to Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the treatment of patients with Epidermal Growth Factor Re ...


Liraglutide is a human glucagon-like peptide 1 analog that may be administered once a day because of its prolonged half-life of 13 hours. Liraglutide was developed to improve glycemic control in p ...


A FDA ( Food and Drug Administration ) study of more than 134,000 Medicare patients found that Pradaxa ( Dabigatran etexilate mesylate ) was associated with significantly reduced risks of ischemic str ...


The European Commission has approved Imbruvica ( Ibrutinib ) capsules, a first-in-class, once-daily, oral Bruton's tyrosine kinase ( BTK ) inhibitor. Ibrutinib works by blocking BTK, a protein that ...


The FDA ( Food and Drug Administration ) has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio ( Teriflunomide ) in the product’s U.S. lab ...


The Food and Drug Administration ( FDA ) has approved Otezla ( Apremilast ), oral, selective inhibitor of phosphodiesterase 4 ( PDE4 ), for the treatment of patients with moderate to severe plaque pso ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Keytruda ( Pembrolizumab ) for treatment of patients with advanced or unresectable melanoma who are no longer responding to ...


The European Commission has granted marketing authorization for Zydelig ( Idelalisib ), 150 mg tablets, a first-in-class oral treatment for two incurable blood cancers, chronic lymphocytic leukemia ( ...


RPC1063 is a novel, oral, once daily, specific and potent modulator of the sphingosine 1-phosphate 1 receptor ( S1P1R ) pathway, which is a validated G protein-coupled receptor ( GPCR ) target for the ...


Acute myeloid leukaemia ( AML ) is an aggressive and devastating blood cancer. It predominantly affects people over 60 and is one of the most common adult leukaemias in the Western World. The current ...



2000-2014© XAGENA srl - P.IVA: 04454930969 - REA: 1748680 - Tutti i diritti riservati