Novartis $2 million gene therapy for rare disorder is world's most expensive drug

Novartis $2 million gene therapy for rare disorder is world's most expensive drug Swiss drugmaker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants, and priced the one-time treatment at a record $2.125 million.The Food and Drug Administration approved Zolgensma for children...

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FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria

 GSK and Medicines for Malaria Venture (MMV) today announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial...

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FDA Approves Viekira XR

AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application...

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FDA Approves Adlyxin

Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes PARIS, July 27, 2016 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of...

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Massachusetts General Hospital launches phase II trial of BCG vaccine to reverse type 1 diabetes

FDA approval of trial testing generic vaccine announced at ADA Scientific Sessions A phase II clinical trial testing the ability of the generic vaccine bacillus Calmette-Guérin (BCG) to reverse advanced type 1 diabetes has received approval from the U.S. Food and Drug Administration (FDA). The approval of this trial, which will shortly begin enrolling qualified patients,...

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FDA Approves Antiplatelet Agent Kengreal (cangrelor) as Adjunct to Percutaneous Coronary Intervention

June 22, 2015 — The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or...

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FDA Approves Stiolto Respimat

Stiolto Respimat Generic Name: olodaterol and tiotropium bromideDate of Approval: May 21, 2015Company: Boehringer Ingelheim Pharmaceuticals, Inc. Stiolto Respimat is a combination of the long-acting beta2-adrenergic agonist olodaterol (Striverdi Respimat), and the anticholinergic agent tiotropium (Spiriva Respimat). The U.S. Food and Drug Administration (FDA) has...

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FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures

Fycompa Generic Name: perampanel (per AM pa nel) Brand Names: Fycompa What is Fycompa? Fycompa (perampanel) is an anticonvulsant used to treat seizures.Fycompa is a prescription medicine that is used with other medications to treat partial-onset seizures with or without secondarily generalized seizures, and to treat primary generalized tonic-clonic (PGTC)...

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FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms

June 12, 2015 — The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when...

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