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In combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in people aged two years of age and older [2] Asciminib: Novartis: Treatment of adults with newly diagnosed Philadelphia chromosomepositive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) [2] Blinatumomab
Nearly 6 million Americans have heart failure. Now new devices are available that are more effective, cheaper and more customizable than ever before. New breakthrough treatments for heart failure ...
The Food and Drug Administration has granted Switzerland-based Novartis its "Breakthrough Therapy" (BT) designation for Novartis' acute heart failure (AHF) treatment RLX030 (serelaxin), the ...
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
Guidelines by the American College of Cardiology and the American Heart Association recommend statin treatment for primary prevention of cardiovascular disease in adults with LDL cholesterol ≥ 190 mg/dL (4.9 mmol/L) or those with diabetes, age 40–75 with LDL-C 70–190 mg/dL (1.8–4.9 mmol/dL); or in those with a 10-year risk of developing ...
Image Provided By Unsplash Liver diseases like cirrhosis and nonalcoholic steatohepatitis (NASH) are deadly and afflict millions of Americans with debilitating mental and physical symptoms that ...
If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as: Showing superior effectiveness; Avoiding serious side effects of an available treatment; Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
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