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198 Current news of FDA
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Corautus Genetics Receives FDA Fast Track Designation for VEGF-2
07-11-2005
Corautus Genetics Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to Corautus for Vascular Endothelial Growth Factor 2 ("VEGF-2") for the treatment of severe angina associated with cardiovascular disease. Richard E. Otto, President and ...
BG Medicine and FDA to Conduct Biomarker Discovery Study to Improve Prediction of Human Liver Toxicity in Drug Development
Study to Provide Solutions to Primary Obstacles in the Development of New Pharmaceuticals
27-10-2005
BG Medicine announced the submission of a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's National Center for Toxicological Research (NCTR), to conduct jointly a liver toxicity study designed to overcome one of the primary obstacles to the ...
FDA selects Ingenix fpr drug safety monitoring and support
New Technology to Help Accelerate Identification of Drug Safety Signals
04-10-2005
Ingenix, a wholly owned subsidiary of UnitedHealth Group has been selected by the United States Food and Drug Administration (FDA) to help improve the effectiveness and speed of safety evaluations for pharmaceutical agents. The Ingenix program is built around a team of leading ...
Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope
16-09-2005
Sandoz announced that it has filed a lawsuit against the US Food and Drug Administration, seeking a ruling on its pending new drug application for the human growth hormone Omnitrope. "We believe it is important for patients and health-care providers that cost-effective follow-on protein ...
Amgen Announces FDA Licensure of Two New Manufacturing Facilities
Company Continues to Meet Increased Demand for Its Novel Therapeutics
08-09-2005
Amgen announced the U.S. Food and Drug Administration (FDA) has approved the company's new manufacturing facilities in West Greenwich, Rhode Island, and Juncos, Puerto Rico for the production of Amgen's therapeutics. The new manufacturing plant at Amgen's Rhode Island facility has received ...
FDA Announces Qualified Health Claims for Omega-3 Fatty Acids
08-09-2004
The Food and Drug Administration (FDA) today announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids. Typically, EPA and DHA ...
FDA Approves Viread For HIV-1 Infection
30-10-2001
The Food and Drug Administration has approved Viread (tenofovir disoproxil fumarate), a new antiviral drug indicated for treatment of HIV-1 infection in combination with other antiretroviral medicines. Tenofovir disoproxil fumarate is the first nucleotide analog approved for HIV-1 treatment. ...
FDA Public Health Advisory: Update on Use of Doxycycline for Anthrax Exposure
19-10-2001
Secretary of Health and Human Services Tommy G. Thompson announced on October 17 in testimony before the Committee on Governmental Affairs and Subcommittee on International Security, Proliferation and Federal Services of the United States Senate, that the Food and Drug Administration is ...
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