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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 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 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 ...


The European Commission ( EC ) has approved Entresto ( Sacubitril / Valsartan ) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction ( HFrEF ). Ent ...


The European Commission has approved Nivolumab BMS ( Opdivo ) for the treatment of locally advanced or metastatic squamous ( SQ ) non-small cell lung cancer ( NSCLC ) after prior chemotherapy. This ...


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 Opdivo ( Nivolumab ) to treat patients with advanced ( metastatic ) renal cell carcinoma, who have received a certain type of prior therapy. Op ...


The FDA ( Food and Drug Administration ) granted Priority Review in metastatic melanoma for the supplemental New Drug Application ( sNDA ) for the combination of Tafinlar ( Dabrafenib ) and Mekinist ( ...


The FDA ( Food and Drug Administration ) has granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer ( NSCLC ). Tagrisso ( Osimertinib ) is now ...


Entresto ( Sacubitril / Valsartan ), previously known as LCZ696 has been approved by Health Canada for the treatment of heart failure with reduced ejection fraction ( HFrEF ) in patients with NYHA Cla ...


The FDA ( Food and Drug Administration ) has approved Adcetris ( Brentuximab vedotin ) for the treatment of patients with classical Hodgkin lymphoma ( HL ) at high risk of relapse or progression as po ...


The Committee for Medicinal Products for Human Use ( CHMP ) has recommended the approval of Cosentyx ( Secukinumab ) in Europe to treat ankylosing spondylitis ( AS ) and psoriatic arthritis ( PsA ) pa ...


The FDA ( Food and Drug Administration ) has approved Veltassa ( Patiromer for oral suspension ) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. ...


The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonar ...


Study 205 is a multicenter, randomized, open-label study of Lenvatinib ( 18 mg ) in combination with the anticancer agent Everolimus ( 5 mg ), Lenvatinib alone ( 24 mg ), and Everolimus alone ( 10 mg ...


Researchers have found that Salicylic acid targets the activities of HMGB1, an inflammatory protein associated with a wide variety of diseases, offering hope that more powerful Aspirin-like drugs may ...


Delamanid ( Deltyba ), a nitroimidazo-oxazole derivative, is a new anti-tuberculosis ( TB ) drug which exhibits potent in vitro and in vivo antitubercular activity against drug-susceptible and -resist ...


The FDA ( Food and Drug Administration ) has approved Opdivo ( Nivolumab ) to treat patients with advanced ( metastatic ) non-small cell lung cancer whose disease progressed during or after Platinum-b ...


The FDA ( Food and Drug Administration ) has granted accelerated approval for Keytruda ( Pembrolizumab ) to treat patients with advanced ( metastatic ) non-small cell lung cancer ( NSCLC ) whose disea ...


Epiduo Forte ( Adapalene and Benzoyl peroxide ) Gel, 0.3%/2.5% has been approved by the FDA ( Food and Drug Administration ) for the once-daily, topical treatment of acne vulgaris. Epiduo Forte Gel ...


The Chemotherapy Clinical Reference Group ( CRG ) has reviewed drugs and drug indications for inclusion on the National cancer drugs fund list. The decision summaries record how each drug/drug indica ...



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