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Latest US Food and Drug Administration Stories

2009-02-28 16:28:00

MINNEAPOLIS, Feb. 28 /PRNewswire/ -- In its ongoing contribution to science and the innovation of industry leading nutraceuticals, Eniva Nutraceutics announces the introduction of its new Eniva(R) Cholesterol Reducer(TM) formula. This advanced, liquid nutritional supplement is Eniva's newest heart health product, designed to support healthy cholesterol and homocysteine levels in the body.* The potent cholesterol lowering plant sterol formulation in the Eniva Cholesterol Reducer meets the...

2009-02-26 06:00:00

SOPHIA ANTIPOLIS, France, February 26 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced its financial results for full year 2008 and provided an overview of the development and pre-commercialization activities for naproxcinod, its lead investigational drug for the treatment of the signs and symptoms of osteoarthritis (OA). Michele Garufi, Chief Executive Officer of NicOx, commented: "We believe NicOx has entered 2009 in its strongest strategic position...

2009-02-19 06:48:00

PHILADELPHIA, Pennsylvania and DUBLIN, Ireland, February 19 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company announces results for the year to December 31, 2008 - a year which has seen significant growth in Shire's new product portfolio. Financial Highlights Full Year 2008 (1) Q4 2008 (1) Product sales $2.75bn + 27% $0.70 bn + 7%(3) Product...

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2009-02-10 13:15:00

Reports of the most recent salmonella outbreak have raised a number of concerns among US consumers. In light of the recent outbreak that has killed 8 people and sickened at least 550 nationwide, consumers are becoming exceedingly cautious. "You just don't want to take a chance," Louie Paine, manager of Penny's Noodle Shop in Oak Park, Illinois, told Reuters. Penny's is among a number of businesses that have decided to stop using peanuts in their menu items altogether. In fact, the major US...

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2009-02-05 14:40:00

As more peanut items continue to be added to the list of foods linked to the latest salmonella outbreak, US lawmakers are vowing to create a system of tighter food safety laws and conduct more frequent inspections. Sen. Tom Harkin, D-Iowa, chairman of the Senate Agriculture Committee, on Thursday referred to the US food safety system as "a hit or miss gamble." The committee held a hearing on the outbreak on Thursday. "To say that food safety in this country is a patchwork system is giving it...

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2009-02-04 14:29:18

It appears that the plant allegedly responsible for the latest massive salmonella outbreak owned and operated a Texas plant that had never been inspected by the US Food and Drug Administration until the company came under recent speculation. Although no salmonella was discovered at the Peanut Corp. of America plant in Plainview, news of its under-advised facility have sparked new questions about government's ability to regulate the nation's food supply. In Texas health records obtained by...

2009-02-03 03:00:00

OSLO, Norway, February 3 /PRNewswire-FirstCall/ -- - ALSYMPCA Study Designed to Evaluate Alpharadin for the Treatment of Bone Metastases in Prostate Cancer Patients Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces that it is to enroll US patients into its ALSYMPCA phase III trial evaluating Alpharadin as a new treatment for bone metastases in patients with hormone-refractory prostate cancer (HRPC). This decision follows a successful end-of-phase II meeting*...

2008-09-29 14:40:56

ATLANTA, Sept. 29 /PRNewswire/ -- As a result of a 2004 petition from the Beverage Institute for Health & Wellness (hereafter the Institute) of The Coca-Cola Company , the US Food and Drug Administration (FDA) announced today that it has amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health. The amended rule also includes a broader definition of the populations that could benefit from...

2008-08-30 09:00:22

By Berlin, Jesse A Glasser, Susan C; Ellenberg, Susan S Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems for assessment of postmarketing adverse events include spontaneous reports, computerized...

2008-08-27 09:00:23

EAST HANOVER, N.J., Aug. 27 /PRNewswire/ -- Novartis announced today that Gleevec(R) (imatinib mesylate) tablets* has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST). FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months(1)....


Word of the Day
tesla
  • The unit of magnetic flux density in the International System of Units, equal to the magnitude of the magnetic field vector necessary to produce a force of one newton on a charge of one coulomb moving perpendicular to the direction of the magnetic field vector with a velocity of one meter per second. It is equivalent to one weber per square meter.
This word is named for Nikola Tesla, the inventor, engineer, and futurist.