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  • POM notches legal win in Coke's fruit juice battle Thursday, 12 Jun 2014 | 10:42 AM ET

    POM Wonderful may take Coke to court to accuse it of misleadingly marketing one of its Minute Maid juices, the U.S. Supreme Court said.

  • June 12- Geron Corp said the U.S. Food and Drug Administration lifted a partial clinical hold on a study testing its drug for myelofibrosis, a type of blood cancer, sending its shares soaring about 31 percent in premarket trading. Patient enrollment in the trial, sponsored by Mayo Clinic, was halted in March over concerns of liver toxicity.

  • June 12- Geron Corp said the U.S. Food and Drug Administration lifted a partial clinical hold on a study testing its blood cancer drug, imetelstat, sending its shares soaring about 34 percent in premarket trading. Patient enrollments in the trial, sponsored by Mayo Clinic, were halted in March over concerns of liver damage.

  • June 11- Orexigen Therapeutics Inc said the U.S. Food and Drug Administration delayed a decision on the marketing application for its obesity drug by three months, sending the company's shares down about 19 percent in premarket trading.

  • June 11- Orexigen Therapeutics Inc said the U.S. Food and Drug Administration delayed its decision on the marketing application of its obesity drug, contrave, by three months, sending its shares down about 12 percent in premarket trading.

  • WASHINGTON, June 10- U.S. regulators recommended on Tuesday that pregnant women, nursing mothers and women who might become pregnant increase the amount of low-mercury fish they eat to between eight and 12 ounces a week as they issued a long-awaited draft update to their advice on mercury levels in seafood.

  • June 10- Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration allowed it to resume the development of one of its hepatitis C drugs, lifting a clinical hold that was imposed nearly a year ago.

  • June 10- Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration allowed it to resume the development of one of its hepatitis C drugs, lifting a clinical hold that was imposed nearly a year ago. Achillion submitted additional data on the drug in September, but the FDA maintained the hold.

  • The FDA nonetheless approved it for short-term use because other trials did not show a similar so-called cardiovascular safety signal.

  • WASHINGTON, June 6- The U.S. Food and Drug Administration said on Friday it approved Biogen Idec Inc's long-lasting hemophilia A drug, Eloctate, adding another product to the company's nascent portfolio of drugs for non-malignant blood disorders. The FDA's ruling followed its approval in March of Biogen's hemophilia B treatment, Alprolix.

  • Halozyme shares jump after FDA lifts hold on trial Thursday, 5 Jun 2014 | 7:52 AM ET

    June 5- Shares of Halozyme Therapeutics Inc jumped about 11 percent a day after the U.S. Food and Drug Administration lifted a hold on a trial testing an advanced version of the company's flagship drug delivery technology.

  • June 4- HeartWare International Inc said it received a warning letter from the U.S. Food and Drug Administration following an inspection of its manufacturing plant in Florida in January. HeartWare has also been asked to address issues related to its production and quality procedures and fix problems cited in FDA's inspection.

  • Medical device maker HeartWare gets FDA warning letter Wednesday, 4 Jun 2014 | 7:37 AM ET

    June 4- HeartWare International Inc said it received a warning letter from the U.S. Food and Drug Administration following an inspection of its manufacturing plant in Florida in January. The FDA has not restricted the use of HeartWare devices, the company said in a statement.

  • June 3- Prosensa Holding NV said the U.S. Food and Drug Administration had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder. Prosensa said it would file for European approval in the near future.

  • *Prosensa to conduct two post-approval studies. June 3- Prosensa Holding NV said the U.S. health regulator had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder, sending the company's shares up 5 percent in premarket trading. Prosensa also said it would file for European approval in the near future.

  • June 3- Prosensa Holding NV said the U.S. Food and Drug Administration had outlined a regulatory path for the accelerated approval of its lead drug, sending the company's shares up 15 percent in premarket trading.

  • June 3- Prosensa Holding NV said the U.S. Food and Drug Administration had outlined a regulatory path for the accelerated approval of its lead drug. Prosensa shares were up 15 percent in premarket trading. The Dutch company said on Tuesday it planned to file an application to market the drug in the United States later this year.

  • FDA makes access to public health data easier Monday, 2 Jun 2014 | 11:25 PM ET

    June 2- U.S. Food and Drug Administration on Monday launched openFDA, a project that will make it easier for researchers, mobile application creators, web developers and the general public to access public health data collected by the regulator.

  • Ariad CEO talks Iclusig trials     Monday, 2 Jun 2014 | 12:34 PM ET

    Ariad Pharmaceuticals CEO Dr. Harvey Berger, says investors are responding to his company's better overall picture, and the progress on its leukemia drug Iclusig.

  • *Omeros shares jump 11 pct premarket. June 2- Omeros Corp said the U.S. Food and Drug Administration had approved its drug for use in cataract and lens replacement surgeries, the first drug developed by the company to get marketing clearance from the regulator.