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  • 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..

  • 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.

  • 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.

  • 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.