Topic: Food and Drug Administration
NEW YORK (Reuters) - Johnson & Johnson has cautioned doctors not to begin treatment with its Doxil cancer drug because of shortages of the medicine made by an outside manufacturer.The company had informed doctors last month about a potential shortage of the ...
The US Food and Drug Administration on Monday approved Incivek to treat hepatitis C when taken along with the current two-drug regimen, marking the second such drug approval this month."The sustained virologic response for patients treated with Incivek across all studies, and ...
NEW YORK (Reuters) - Vertex Pharmaceuticals Inc's highly anticipated hepatitis C drug won U.S. approval, heralding a new era of treatment for the liver-destroying condition.The approval, announced by the Food and Drug Administration said on Monday, was widely expected after an FDA ...
US regulators on Friday approved the first new treatment for hepatitis C in more than a decade, a Merck pharmaceutical known as Victrelis, to be taken with the current two-drug regimen.Also known as boceprevir, the drug is a protease inhibitor that prevents ...
An expert panel on Thursday unanimously voted in support of a second new hepatitis C drug, Vertex Pharmaceuticals' telaprevir, which studies suggest can boost cure rates of the liver disease.The advisory panel, which makes recommendations to the Food and Drug Administration, on ...
A US government advisory committee on Wednesday unanimously voted to urge the Food and Drug Administration to approve a new drug made by Merck to fight hepatitis C, a disease which attacks the liver.The advisory committee agreed by a vote of 18-0 ...
SILVER SPRING, Maryland (Reuters) - An experimental drug for the liver-damaging hepatitis C virus offers an advance over the current decade-old treatment that cures only a minority of patients, maker Merck & Co told a U.S. advisory panel on Wednesday.The Merck drug, ...
WASHINGTON (Reuters) - A hepatitis C drug from Vertex Pharmaceuticals Inc cured more patients than previously reported, U.S. health reviewers said, boosting the approval chances for a pill expected to transform treatment of the liver-destroying disease that afflicts millions.Vertex shares rose 12 ...
A cocktail of three drugs, including a new class of antiviral agent, has shown encouraging results in treating hepatitis C, a disease which attacks the liver, a study said Wednesday."This study represents a remarkable advance and a potential cure for people with ...
VRTX) announced today that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C. The NDA submission is supported by results ...
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