Drugs Xagena
The U. S. Food and Drug Administration ( FDA ) has approved Opdivo ( Nivolumab ), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck ( SCCHN ) with ...
The FDA ( Food and Drug Administration ) has approved a new indication for Jardiance ( Empagliflozin ) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established ...
The European Medicines Agency's ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for the use of Alecensa ( Alectinib ) for the treatment of adult patients ...
The Food and Drug Administration ( FDA ) has approved Keytruda ( Pembrolizumab), an anti-PD-1 ( programmed death receptor-1 ) therapy, for the first-line treatment of patients with metastatic non-smal ...
The FDA ( Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) for the treatment of people with metastatic non-small cell lung cancer ( NSCLC ) who have disease progression during or ...
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 European Commission ( EC ) has approved Trodelvy ( Sacituzumab govitecan ) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2 ...
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 US Food and Drug Administration ( FDA ) has approved Biologics License Application ( BLA ) for Nucala ( Mepolizumab ) as an add-on maintenance treatment of patients with severe asthma aged 12 year ...
Targin ( Targinact, Targiniq ), a fixed combination of prolonged-release Oxycodone / Naloxone, has received a positive European Commission ( EC ) decision for a new indication, as a second line sympto ...
Strensiq, an innovative enzyme replacement therapy ( ERT ), is the first therapy approved in the U.S. for the treatment of patients with HPP, a genetic, chronic, and progressive ultra-rare metabolic ...
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 ...
