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Tag: fda
Merck Statement on FDA Advisory Committee Meeting on IMPROVE-IT Study with VYTORIN (ezetimibe and simvastatin)
2015-12-15 00:23:15| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, issued today the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss the results of IMPROVE-IT, an investigational study comparing treatment with VYTORIN (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes. Language: English read more
Tags: statement
study
meeting
committee
FDA approves Genentech drug for advanced lung cancer
2015-12-11 23:03:49| Biotech - Topix.net
The Food and Drug Administration on Friday conditionally approved an experimental Genentech drug for patients with a certain type of lung cancer who have few other options. Alecensa won accelerated approval for patients with advanced non-small cell lung cancer with a mutation in a gene called ALK who have relapsed after treatment with Pfizer Inc.'s Xalkori or who could not tolerate that drug.
Tags: advanced
drug
cancer
lung
Teva Gets FDA Approval For Cancer Drug
2015-12-08 17:23:41| Biotech - Topix.net
Israel's Teva Pharmaceutical Industries said the U.S. Food and Drug Administration approved an injectable and infusion version of its cancer drug bendamustine. The drug, sold under the brand name Bendeka, is approved for treating cancer patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.
Tags: drug
approval
cancer
fda
FDA Updates Registration List
2015-12-07 21:00:00| Happi Breaking News
VCRP monthly status report.
Tags: list
registration
updates
fda
FDA Finds Consumer Definitions of 'Natural' Food Headspinning
2015-12-04 22:40:00| Food Processing
The FDA will have its work cut out for it when it tries to come up with a workable definition of natural, if the comments submitted so far are indication.
Tags: food
natural
consumer
finds
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