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The European Medicines Agency ( EMA ), the Committee for Medicinal Products for Human Use ( CHMP ), and the European Commission ( EC ) have granted market authorization renewal for Angiox ( Bivalirudi ...


A phase III clinical trial ( Study 332 ) of AMPA receptor antagonist Perampanel ( Fycompa ) has met its primary endpoints in patients with primary generalized tonic-clonic ( PGTC ) seizures, one of th ...


The FDA ( Food and Drug Administration ) has approved Sivextro ( Tedizolid phosphate ), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved to treat patients with a ...


The FDA ( Food and Drug Administration ) has approved Afrezza ( Insulin human ) inhalation powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezz ...


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Reasanz, intended for the ...


The FDA ( Food and Drug Administration ) has approved Beleodaq ( Belinostat ) for the treatment of patients with peripheral T-cell lymphoma ( PTCL ), a rare and fast-growing type of non-Hodgkin lympho ...


Dimethyl fumarate ( BG-12, Tecfidera ) is a new oral drug approved by FDA ( Food and Drug Administration ) and EMA ( European Medicines Agency ) for relapsing-remitting multiple sclerosis ( RRMS ). ...


The FDA ( Food and Drug Administration ) has approved Entyvio ( Vedolizumab ) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Cr ...


Multiple myeloma, a cancer of white blood cells predominantly affecting the bone marrow, impacts approximately 1 to 5 in every 100,000 people worldwide each year. With a five-year survival rate of 44% ...


The FDA ( Food and Drug Administration ) has approved Eloctate, antihemophilic factor ( recombinant ), Fc fusion protein, for use in adults and children who have hemophilia A. Eloctate is the first ...


The FDA ( Food and Drug Administration ) has approved the first generic versions of Celebrex ( Celecoxib ) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term ( acute ) pain, an ...


The FDA ( Food and Drug Administration ) has approved Siltuximab ( Sylvant ), for the treatment of patients with multicentric Castleman’s disease ( MCD ) who are human immunodeficiency virus ( HIV- ) ...


Pradaxa ( Dabigatran etexilate ) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ). The FDA ( F ...


The European Commission has granted marketing authorisation for Empagliflozin ( Jardiance ), a sodium glucose cotransporter 2 ( SGLT2 ) inhibitor. Empagliflozin has been approved for the treatment of ...


The FDA ( Food and Drug Administration ) has approved Zontivity ( Vorapaxar ) tablets to reduce the risk of myocardial infarction, stroke, cardiovascular death, and need for procedures to restore the ...


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Translarna, intended for t ...


Novartis has announced that the European Commission ( EC ) has approved the use of Xolair ( Omalizumab ) as an add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent ...


Empagliflozin is an oral selective SGLT-2 inhibitor that acts by blocking the reabsorption of glucose in the proximal tubules in the kidneys, and promotes excretion of excess glucose in the urine. ...


The aim of this study was to evaluate the safety and tolerability of Sitagliptin ( Januvia ) 100 mg/day in elderly patients with type 2 diabetes mellitus. A post hoc pooled analysis of 25 randomize ...


Pfizer has announced top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials ( OPT ) Program, OPT Pivotal #1 ( A3921078 ) and OPT Pivotal #2 ( A3921079 ), evaluating ...


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Adempas, 0.5 mg, 1 mg, 1.5 ...


Novartis has announced that the Data Monitoring Committee ( DMC ) unanimously recommended early closure of the PARADIGM-HF study, indicating patients with chronic heart failure with reduced ejection f ...


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masiviera, intended for th ...


The FDA ( Food and Drug Administration ) Cardiovascular and Renal Drugs Advisory Committee ( CRDAC ) voted against approval for Serelaxin ( Reasanz ) for the treatment of acute heart failure ( AHF ). ...


The FDA ( Food and Drug Administration ) granted accelerated approval of Northera ( Droxidopa ) for the treatment of symptomatic neurogenic orthostatic hypotension ( NOH ). Northera is the first and o ...


The Food and Drug Administration ( FDA ) has approved Vimizim ( Elosulfase alfa ), the first FDA-approved treatment for mucopolysaccharidosis type IVA ( Morquio A syndrome ). Morquio A syndrome is a r ...


Eli Lilly has announced that the REVEL trial, a global phase III study of Ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung cancer ( NSCLC ), showed a stati ...


Sclerostin is an osteocyte-derived inhibitor of osteoblast activity. The monoclonal antibody Romosozumab binds to sclerostin and increases bone formation.In a phase 2, multicenter, international, rand ...


The FDA ( Food and Drug Administration ) has approved Mekinist ( Trametinib ) in combination with Tafinlar ( Dabrafenib ) to treat patients with advanced melanoma that is unresectable or metastatic.In ...


The FDA ( Food and Drug Administration ) has approved Hetlioz ( Tasimelteon ), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder ( non-24 ) in totally blind individuals. Non-24 i ...


The CHMP ( European Committee for Medicinal Products for Human Use ) has recommended approval for Riociguat tablets for use in two forms of pulmonary hypertension, a group of life-threatening and prog ...


Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 ( PCSK9 ). PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces ...


In the Ongoing Telmisartan Alone and in Combination with Ramipril Trial ( ONTARGET ), dual agent renin-angiotensin-aldosterone system ( RAAS ) blockade with angiotensin-converting-enzyme inhibitors ( ...


Current standard immunomodulatory therapy with interferons ( IFNs ) for relapsing-remitting multiple sclerosis exhibits proven, but limited, efficacy and increased side effects due to the need of freq ...


Inhaled corticosteroids such as Beclometasone are the drugs of choice for long-term treatment of patients with persistent asthma. There is no tangible difference in efficacy among inhaled corticoste ...


The FDA ( U.S. Food and Drug Administration ) has approved Breo Ellipta ( Fluticasone furoate and Vilanterol inhalation powder ) for the long-term, once-daily, maintenance treatment of airflow obstruc ...


The FDA ( Food and Drug Administration ) has approved Kynamro ( Mipomersen sodium ) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholester ...


Positive results from a six month pivotal phase III clinical trial evaluating the efficacy and safety of fixed dose combinations of Aclidinium bromide ( LAMA ) and Formoterol fumarate ( LABA ) deliver ...


Edoxaban ( Lixiana, Savaysa ) is an oral factor Xa ( FXa ) inhibitor in clinical development for stroke prevention in patients with atrial fibrillation, an elderly population that frequently receives ...


Dapsone is used in the treatment of infections and inflammatory diseases. The Dapsone hypersensitivity syndrome, which is associated with a reported mortality of 9.9%, develops in about 0.5 to 3.6% of ...


Velphoro ( Sucroferric oxyhydroxide ) has been approved by FDA ( Food and Drug Administration ) for the control of serum phosphorus levels in patients with chronic kidney disease ( CKD ) on dialysis.V ...


The European Commission granted marketing authorization for Brintellix ( Vortioxetine ) for the treatment of adults with major depressive episodes. The European approval follows approval by the FDA ( ...


The FDA ( Food and Drug Administration ) has approved Sovaldi ( Sofosbuvir ) to treat chronic hepatitis C virus ( HCV ) infection. Sovaldi is the first drug that has demonstrated safety and efficacy t ...


The FDA ( Food and Drug Administration ) has approved a new use for Xiaflex ( Collagenase Clostridium histolyticum ) as the first FDA-approved medicine to treat men with bothersome curvature of the pe ...


The European Medicines Agency’s ( EMA’s ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending extending the European Union marketing authorization for t ...


Roche has announced that Kadcyla ( Trastuzumab emtansine or T-DM1 ) has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer.Specifically, K ...


The FDA ( Food and Drug Administration ) has expanded the approved uses of Nexavar ( Sorafenib ) to treat metastatic differentiated thyroid cancer.Sorafenib works by inhibiting multiple proteins in ca ...


European Commission ( EC ) has approved the use of Ilaris ( Canakinumab ) in the treatment of active systemic juvenile idiopathic arthritis ( SJIA ) in patients aged 2 years and older, who have respon ...


European Commission ( EU ) has granted marketing authorization for Aubagio ( Teriflunomide ) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting mu ...


Xarelto ( Rivaroxaban ), a novel oral anticoagulant, has been approved by the European Commission ( EC ) for the prevention of atherothrombotic events ( cardiovascular death, myocardial infarction or ...