Drugs Xagena
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 ...
Merck Serono has announced that the European Commission ( EU ) has approved the type II variation to amend the Erbitux ( Cetuximab ) product information, updating the indication for Erbitux to the tre ...
Results for VEGF Trap-Eye ( Aflibercept ophthalmic solution; Eylea ) from the phase 3 MYRROR study in myopic choroidal neovascularization ( mCNV ) were presented. In this trial, patients receiving VEG ...
The Food and Drug Administration ( FDA ) has approved two new drugs, Tafinlar ( Dabrafenib ) and Mekinist ( Trametinib ), for patients with advanced ( metastatic ) or unresectable melanoma, the most d ...
The Food and Drug Administration ( FDA ) has expanded the use of Xgeva ( Denosumab ) to treat adults and some adolescents with giant cell tumor of the bone ( GCTB ), a rare and usually non-cancerous t ...
The FDA ( Food and Drug Administration ) has announced that it has approved heptavalent botulism Antitoxin ( A, B, C, D, E, F, G )-( Equine ) to treat patients showing signs of botulism following docu ...
The FDA ( Food and Drug Administration ) has approved Tobi Podhaler ( Tobramycin inhalation powder ) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes ...
The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with relapsing forms of multiple sclerosis.Multiple sclerosis is a chronic, inflammatory, ...
The FDA ( Food and Drug Administration ) has approved Invokana ( Canagliflozin ) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.Type 2 diabetes is the ...
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 Ultibro Breezhaler, 85 mcg/ ...
Eli Lilly has announced today that it will discontinue the phase 3 rheumatoid arthritis program for Tabalumab, an anti-BAFF ( B cell activating factor ) monoclonal antibody, due to lack of efficacy. T ...
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 Tybost, 150 mg, film-coated ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for Incresync, 12.5 mg / 45 mg, 12.5 mg / 30 mg, 25 m ...
The Food and Drug Administration ( FDA ) has approved Cimzia ( Certolizumab pegol ) for the treatment of adults with active ankylosing spondylitis ( AS ). The FDA also issued a Complete Response Lette ...
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 Grastofil, 30 MU/0.5 ml and ...
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 Giotrif 20 mg, 30 mg, 40 mg ...
Takeda officially notified the Committee for Medicinal Products for Human Use ( CHMP ) that it wishes to withdraw its application for a marketing authorisation for Omontys, for the treatment of sympto ...
Cangene Europe has notified the Committee for Medicinal Products for Human Use ( CHMP ) that it wishes to withdraw its application for a marketing authorisation for IXinity, for the treatment and prev ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Vectibix.The C ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Velcade ( Bort ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Tyverb ( Lapat ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Onglyza ( Saxa ...
The European Commission ( EC ) has approved extension application regarding the use of antiepileptic agent Zonegran ( Zonisamide ) in the treatment of paediatric patients. The approval extends the use ...
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 Lojuxta, 5mg, 10mg, 20mg ha ...
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 Voncento.Voncento is recomm ...
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 Evarrest Sealant Matrix.The ...
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 Cholib 145mg/40mg and 145mg ...
