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  • 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.

  • 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.

  • 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.

  • 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.

  • Aug 28- Johnson& Johnson is recalling some lots of its implant used to correct defects of the jaw, following more than a dozen cases of injury.

  • 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. OncoMed is developing the drug in collaboration with Germany's Bayer AG. The FDA formally placed a partial hold on vantictumab, following the voluntary halt.

  • FDA says Johnson & Johnson recalls some jaw implants Thursday, 28 Aug 2014 | 8:17 AM ET

    Aug 28- Johnson& Johnson is recalling some lots of its implant used to correct defects of the jaw following more than a dozen cases of injury. The device, which is used to lengthen and stabilize the lower jawbone and the side of the lower jaw, is being recalled by JNJ unit DePuy Synthes as it may reverse after surgery.

  • Aug 25- Regado Biosciences Inc said it stopped enrollment in a late-stage trial of its lead drug after an independent safety panel raised serious concerns of allergic reactions, sending the company's shares down about 26 percent before the bell. The U.S. Food and Drug Administration also imposed a clinical hold on the trial.

  • Aug 15- Acura Pharmaceuticals Inc said the U.S. Food and Drug Administration indicated that the company may have to conduct an additional study to determine the abuse-deterrent capability of its experimental painkiller treatment. The FDA in May said data was insufficient to support the company's claim that the drug could not be abused by snorting.

  • Kevin Conroy, Exact Sciences chairman & CEO, provides details on a potential major breakthrough in the fight against colon cancer.

  • FDA approves first DNA-based test for colon cancer Tuesday, 12 Aug 2014 | 6:47 AM ET

    The FDA approved the first screening test for colon cancer that uses patients' DNA to help spot potentially deadly tumors and growths.