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  • Drugmaker submits harder-to-abuse Zohydro to FDA Wednesday, 1 Oct 2014 | 1:24 PM ET

    WASHINGTON— The maker of the much-debated painkiller Zohydro is seeking approval of a harder-to-abuse version of its drug which, if approved, could replace the currently marketed version of the pill by next spring.

  • Sept 29- Salix Pharmaceuticals Ltd said the U.S. Food and Drug Administration approved an expanded use of its constipation treatment. It will compete with Nektar Therapeutics and AstraZeneca Plc's oral drug Movantik, approved by the FDA earlier this month for the same patient population.

  • Sept 29- Salix Pharmaceuticals Ltd said the U.S. Food and Drug Administration approved an expanded use of its constipation treatment. Salix, which is merging with Cosmo Pharmaceuticals SpA's Irish subsidiary, is in talks with Allergan Inc and Actavis Plc about a potential sale, sources have told Reuters in recent weeks.

  • Sept 29- Tonix Pharmaceuticals Holding Corp said its lead pain drug failed the main goal of a mid-stage study, sending its shares down by nearly half in premarket trading. Tonix said it plans to discuss the trial results and the design for a late-stage trial with the U.S. Food and Drug Administration.

  • Sept 26- Alimera Sciences Inc and pSivida Corp said the U.S. Food and Drug Administration approved their vision-loss treatment Iluvien, following three rejections. Iluvien, which will compete with Regeneron Pharmaceuticals Inc's Eylea and Roche AG's Lucentis, is expected to be available in the United States in early 2015..

  • AbbVie gets new approval for its drug Humira Thursday, 25 Sep 2014 | 11:03 AM ET

    NEW YORK— AbbVie said Thursday that U.S. regulators approved its drug Humira as a treatment for Crohn's disease in children. The Food and Drug Administration cleared Humira as a treatment for moderate to severe Crohn's disease in children ages 6 and older when those children haven't been helped by other treatments, AbbVie said.

  • Pacira shares drop as FDA warns on misleading ads Thursday, 25 Sep 2014 | 9:14 AM ET

    PARSIPPANY, N.J.— Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading. "These claims overstate Exparel's efficacy and are misleading," the FDA said in the letter.

  • FDA issues warning letters on Ebola treatment claims Wednesday, 24 Sep 2014 | 3:26 PM ET

    Sept 24- The U.S. Food and Drug Administration issued warning letters to three privately held companies marketing treatments that claim to prevent or treat Ebola. The letters were sent to Newton, New Jersey- based Natural Solutions Foundation, Utah- based dTERRA International LLC and Utah- based Young Living.

  • NEW YORK, Sept 23- Galmed Pharmaceuticals Ltd soared on Tuesday after the company said the Food and Drug Administration had granted fast track designation for its product candidate, aramchol, designed to treat non-alcoholic steato-hepatitis.

  • Sept 22- Canadian drugmaker Tekmira Pharmaceuticals Corp said the U.S. Food and Drug Administration had authorized emergency use of its Ebola treatment to confirmed or suspected patients under an expanded access protocol.

  • 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.

  • 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.