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  • FDA revises food safety rules due next year Friday, 19 Sep 2014 | 9:22 AM ET

    WASHINGTON— The Food and Drug Administration on Friday revised sweeping food safety rules proposed last year after farmers complained that the regulations could hurt business.

  • FDA approves Eli Lilly's injectable diabetes drug Thursday, 18 Sep 2014 | 4:41 PM ET

    WASHINGTON— The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease.

  • The drug, developed by Vivus Inc, is marketed in the United States and Canada by Auxilium Pharmaceuticals Inc. Vivus' stock was up about 13 percent at $4.40 in afternoon trading.

  • The drug was developed by Auxilium Pharmaceuticals Inc and Vivus Inc.. Vivus owns the worldwide development and commercial rights to Stendra for use in sexual dysfunction, with the exception of certain Asian countries in the Pacific Rim.

  • The drug, developed by Vivus Inc, is marketed in the United States and Canada by Auxilium Pharmaceuticals Inc. Vivus' stock was up about 13 percent at $4.40 in afternoon trading.

  • FDA OKs faster-acting label for ED drug Stendra Thursday, 18 Sep 2014 | 8:21 AM ET

    Federal regulators have approved a new label for Vivus' impotence drug, stating that it becomes effective in half the time that the previous label had stated. But Vivus has sought a new label after finding in studies that some patients were able to have sex as little as 15 minutes.

  • Sept 18- An erectile dysfunction drug that reduces by half the time patients need to take the pill before sexual activity has been approved by the U.S. Food and Drug Administration.

  • Sept 17- Testosterone replacement therapies should be reserved for men with specific medical conditions that impair function of the testicles, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

  • WASHINGTON, Sept 11- Novo Nordisk's drug liraglutide is safe and effective enough to warrant approval for use in chronically obese patients with at least one weight-related health issue, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. It would be sold under the name Saxenda if approved for obesity by the FDA.

  • FDA panel backs Novo Nordisk injection for obesity Thursday, 11 Sep 2014 | 4:16 PM ET

    The FDA first approved the drug, liraglutide, under the brand name Victoza in 2010 as a daily injection for type 2 diabetes, in which the body does not properly use insulin. Danish drugmaker Novo Nordisk now wants the FDA to approve the drug as an obesity treatment based on company studies showing significant weight loss in most patients.

  • WASHINGTON, Sept 11- Novo Nordisk's drug liraglutide is safe and effective enough to warrant approval for use in chronically obese patients with at least one weight-related health issue, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

  • FDA approves weight-loss drug Contrave Thursday, 11 Sep 2014 | 6:53 AM ET

    Contrave joins two similar drugs from Arena Pharmaceuticals and Vivus Inc. which FDA approved in 2012 after a 13- year drought of new prescription weight-loss medicines. But sales of Vivus' Qsymia and Arena's Belviq have been far below expectations due to limited insurance coverage and high out-of-pocket costs for patients.

  • Long-awaited diet pill gets U.S. approval Wednesday, 10 Sep 2014 | 9:00 PM ET

    Sept 10- A new diet pill Contrave got approval to be sold in the United States on Wednesday, only the third obesity treatment in more than a decade to win approval from the Food and Drug Administration.

  • US STOCKS-NPS soars after preliminary review from FDA Wednesday, 10 Sep 2014 | 9:10 AM ET

    NEW YORK, Sept 10- NPS Pharmaceuticals Inc rose sharply in premarket trading on Wednesday, after a preliminary review by the Food and Drug Administration said the company's hormone replacement therapy Natpara reduced the need for calcium and vitamin D supplements in clinical trials.

  • WASHINGTON, Sept 9- Novo Nordisk's drug liraglutide appears effective in treating obesity, though safety questions remain, according to a preliminary assessment by reviewers at the U.S. Food and Drug Administration.

  • Keryx Biopharma gets U.S. approval for kidney drug Friday, 5 Sep 2014 | 11:28 AM ET

    Sept 5- Keryx Biopharmaceuticals Inc won the U.S. Food and Drug Administration approval for its drug to lower phosphate levels in patients with chronic kidney disease who are already on dialysis. It affects more than 20 million adults in the United States, according to the U.S. Centers for Disease Control and Prevention.

  • Sept 4- NewLink Genetics Corp said the U.S. Food and Drug Administration allowed the company to start testing an experimental Ebola vaccine in humans. The move follows a decision to begin initial human testing of a GlaxoSmithKline vaccine this month and an approval to fast track tests of a Johnson& Johnson vaccine.

  • NewLink says FDA allows human testing of Ebola vaccine Thursday, 4 Sep 2014 | 7:28 AM ET

    Sept 4- NewLink Genetics Corp said the U.S. Food and Drug Administration allowed the company to start testing an experimental Ebola vaccine in humans.

  • GE's 3D mammography device gets U.S. FDA approval Tuesday, 2 Sep 2014 | 9:34 PM ET

    Sept 2- General Electric Co's healthcare unit last week won U.S. Food and Drug Administration approval for its mammography device that produces three-dimensional images to detect breast cancer. Hologic Inc came up with one of the first 3- D breast imaging devices in 2001, which continues to dominate the market.

  • Aug 28- OncoMed Pharmaceuticals Inc said the U.S. Food and Drug Administration lifted a partial hold on patient enrolments for three trials testing its experimental cancer drug, vantictumab.