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Wednesday, April 7, 2010 as of 11:14 AM ET

Food And Drug Administration

Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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Roche Cancer Drug Avastin Slows Ovarian Cancer Progression - Study

Adding the cancer drug Avastin to a treatment regimen for women with advanced ovarian cancer helped extend the time before the disease progressed, according to a new study that will be presented Saturday.

Avastin, made by Roche's (RHHBY, ROG.VX) Genentech unit, is a drug designed to shut down blood vessels that fuel tumor growth.The drug is approved in the U.S. to treat colon, lung and other cancers, typically in addition to chemotherapy. Last year the U.S. Food and Drug Administration revoked the approval of the drug for use in advanced breast cancer, saying the drug carried potentially life-threatening side effects and didn't appear to slow the progression of breast cancer.Roche has sponsored four clinical studies testing Avastin for use in treating ovarian cancer. Data from one of those studies will be presented Saturday at the American Society of Clinical Oncology's annual meeting in Chicago.The study involved 361 patients whose disease had been previously treated with platinum-base...

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  1. Bayer Backs Xarelto Sales Forecast After FDA Panel Votes Against Expanded Use

    German pharmaceutical company Bayer AG (BAYN.XE) Thursday confirmed it sees peak annual sales of its Xarelto drug above EUR2 billion after a U.S. Food and Drug Admin...

  2. FDA Panel Votes Against Expanded Approval Of Bayer, J&J's Xarelto

    A Food and Drug Administration advisory panel narrowly voted against expanded use of Johnson & Johnson's (JNJ) and Bayer AG's (BAYRY, BAYN.XE) anticlotting drug Xare...

  3. Bayer Submits Regorafenib For EU, US. Marketing Authorization

    German pharmaceutical company Bayer AG's (BAYN.XE) HealthCare unit Wednesday said it applied for marketing authorization in the E.U. and the U.S. for its oral drug R...

  4. FDA Reviewer Recommends Against Approval Of Pfizer Drug

    A Food and Drug Administration medical reviewer recommended the agency not approve a drug developed by a Pfizer Inc. (PFE) subsidiary to treat a rare genetic disorde...

  5. Beware of Phony Pharmaceuticals

    Author Roger Bate on the growing dangers associated with imported ingredients in pharmaceuticals.

  6. Chinese Company Buys AMC for $2.6B

    University of Maryland Economist Peter Morici on the potential risks from Chinese acquisitions of U.S. companies.

  7. J&J's Simponi Helps Colitis Patients In Clinical Trial

    Johnson & Johnson (JNJ) said its drug Simponi improved symptoms in a majority of patients with an inflammatory-bowel disease in a new clinical trial.The results, rel...

  8. FDA Reviewer Backs Expanded Approval Of Bayer, J&J's Xarelto

    A Food and Drug Administration medical reviewer recommended the agency expand the approval of Johnson & Johnson's (JNJ) and Bayer AG's (BAYRY, BAYN.XE) anticlotting ...

  9. FDA Reviewer Recommends Expanded Approval Of Bayer, J&J's Xarelto

    A Food and Drug Administration medical reviewer recommended the agency expand the approval of Johnson & Johnson's (JNJ) and Bayer AG's (BAYRY, BAYN.XE) anticlotting ...

  10. Regulators Recommend Approval of Over-the-Counter HIV Test

    Orasure Technologies CEO Douglas Michels on efforts to get FDA approval of the first over-the-counter HIV test and make it available to consumers by the summer.

  11. WSJ BLOG/Health: A.M. Vitals: New Alzheimer's Trial; Home HIV Test

    Here's what's making health news this morning:New Bid to Prevent Alzheimer's Early (WSJ): An Alzheimer's drug to be tested mostly on an extended family predisposed t...

  12. WSJ BLOG/Health: New Caution Urged Over Sole Oral MS Drug On the Market

    The FDA says the only oral multiple-sclerosis drug on the market -- Novartis's Gilenya -- shouldn't be used in patients with a recent history of stroke or some heart...

  1. WSJ BLOG/Health: Reader Consult: Sweet or Sour on FDA's High Fructose Corn Syrup Decision?

    The U.S. Food and Drug Administration's rejection of a request to change the name of high-fructose corn syrup to "corn sugar" unleashed a torrent of responses from i...

  2. State Audit Finds Problems With 529 Plan in Illinois

    Illinois State Rep. Jim Durkin on an audit showing the state’s college tuition savings program is $560 million short of its projected obligations.

  3. Pronova Wins Heart-Drug Patent Case Against Teva, Par Pharma

    A Delaware court has ruled in favor of Pronova BioPharma ASA (PRON.OS, PVNAY), upholding two patents for its heart drug Lovaza against Par Pharmaceutical Cos. (PRX) ...

  4. Mylan Launches Generic Version of Blockbuster Lipitor

    Mylan Inc. (MYL) has launched a generic version of Pfizer Inc.'s (PFE) blockbuster cholesterol Lipitor after receiving approval from the U.S. Food and Drug Administr...

  5. JNJ Janssen Unit: FDA Letter Rejects 800mg-Prezista

    A Johnson & Johnson (JNJ) unit said its supplemental new drug application for a once-daily oral treatment of Prezista to treat HIV received a preliminary rejection f...

  6. Ranbaxy's Canadian Partner Gets Regulatory OK To Sell Acne Treatment In US

    Ranbaxy Laboratories Ltd. (500359.BY) said Monday Canadian partner Cipher Pharmaceuticals Ltd. (DND.T) has received U.S. regulatory approval to make and sell a paten...

  7. FDA Panel: Data Could Support Approval Of Pfizer Drug Tafamidis

    A Food and Drug Administration advisory panel said a clinical study submitted by Pfizer Inc. (PFE) for a drug to treat a rare genetic disorder that affects the nervo...

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