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198 Current news of FDArss
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 ...
Study to Provide Solutions to Primary Obstacles in the Development of New Pharmaceuticals
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 ...
New Technology to Help Accelerate Identification of Drug Safety Signals
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 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 ...
Company Continues to Meet Increased Demand for Its Novel Therapeutics
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 ...
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 ...
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. ...
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 ...