je.st
news
Tag: fda safety
FDA overturns safety limits on diabetes drug
2013-11-25 23:23:10| Biotech - Topix.net
The repeal means patients will no longer have to enroll in a special registry to be eligible to receive the drug.
Tags: safety
drug
limits
diabetes
FDA Approves U.S. Product Labeling Update For Sprycel (Dasatinib) To Include Three-Year First-Line And Five-Year Second-Line Efficacy And Safety Data In Chronic Myeloid Leukemia In Chronic Phase
2013-06-20 16:10:00| dairynetwork News Articles
Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) product labeling. The labeling now includes three-year efficacy and safety data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and five-year data in CP Ph+ CML patients who are resistant or intolerant to Gleevec®1 (imatinib mesylate)
FDA considers lifting safety limits on Avandia
2013-06-03 18:52:19| Biotech - Topix.net
A former blockbuster diabetes pill which was subjected to major safety restrictions in 2010 may not be as risky as once thought, according to the latest analysis of the much-debated GlaxoSmithKline drug.
Tags: safety
limits
considers
lifting
FDA has safety concerns with Merck insomnia drug
2013-05-20 21:15:54| Biotech - Topix.net
The Food and Drug Administration on Monday released its review of the company's sleep aid, suvorexant, ahead of a public meeting on Wednesday.
Tags: safety
drug
concerns
fda
Court Orders FDA to Implement Food Safety Rules
2013-04-29 21:44:00| National Hog Farmer
By P. Scott Shearer, Bockorny Group, Washington, DC The U.S. District Court in San Francisco has ordered the Food & Drug Administration (FDA) to establish a new timetable to implement regulations for the 2011 Food Safety Modernization Act (FSMA). read more
Tags: food
orders
rules
safety