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  • Correction: Blue Bell-Listeriosis story Tuesday, 17 Mar 2015 | 5:48 PM ET

    DALLAS— In stories on March 13-14 about listeria contamination of some Blue Bell products, The Associated Press reported erroneously that the Food and Drug Administration found listeria bacteria in 10 Blue Bell frozen novelty products. 3 Kansas hospital patients die of ice cream-related illness. Five people, in all, developed listeriosis in Kansas after...

  • The review comes two days ahead of a meeting of FDA advisers to discuss the combination treatment, Breo Ellipta, and recommend whether or not it should be approved to treat asthma. The FDA staff said on Tuesday there were no asthma-related deaths in Breo Ellipta studies it reviewed and that data on asthma-related hospitalizations were not observed uniformly...

  • March 17- GlaxoSmithKline Plc's respiratory treatment for chronic breathing problems did not show any new safety problems in treating asthma, a preliminary review by U.S. Food and Drug Administration staff found. The review comes two days ahead of a meeting of FDA advisers to discuss the combination treatment, Breo Ellipta, and recommend whether or not it...

  • March 16- An independent panel to the U.S. Food and Drug Administration recommended unblinding a late-stage study testing Pharmacyclics Inc and Johnson& Johnson's Imbruvica, after the treatment was successful in treating two types of cancer in combination with other drugs. Pharmacyclics, which recently agreed to be acquired by AbbVie Inc, said Imbruvica...

  • March 12- Pfizer Inc's pain drug, Lyrica, failed a post-marketing study testing the treatment in adolescents with fibromyalgia, a chronic disorder characterized by widespread musculoskeletal pain, fatigue, and tenderness in localized areas. Pfizer conducted the trial to meet U.S. Food and Drug Administration requirements after Lyrica was approved for the...

  • UPDATE 1-FDA says panel to discuss "superbug" spread Thursday, 12 Mar 2015 | 10:46 AM ET

    The gastroenterology and urology devices panel would meet on May 14-15, FDA said on Thursday. A top FDA official said earlier this month that manufacturers' tests of procedures to clean medical scopes linked with "superbug" outbreaks contained flaws that render their cleaning instructions unreliable. Olympus Corp, Fujifilm Holdings Corp and Pentax Medical...

  • FDA says panel to discuss "superbug" spread Thursday, 12 Mar 2015 | 10:07 AM ET

    March 12- The U.S. Food and Drug Administration said an advisory panel will discuss the transmission of "superbug" infections through certain procedures in U.S. hospitals. The regulator said the gastroenterology and urology devices panel would meet on May 14-15. The planned meeting comes after reports that manufacturers' tests of procedures to clean medical...

  • In a letter released on Wednesday, the organization urged Health and Human Services Secretary Sylvia Burwell to withdraw the proposal, saying pharmaceutical companies could "sell more drugs by making them seem safer than FDA has judged them to be." The FDA said it would allow distribution of new information in medical journals showing that the severity or...

  • 'Share the Journey' app new tool in cancer fight Tuesday, 10 Mar 2015 | 4:51 PM ET
    Game changer for health research

    The app will work with Apple's ResearchKit and turn devices into a diagnostic tool for a range of diseases including Parkinson's and breast cancer.

  • March 10- The U.S. Food and Drug Administration said it approved United Therapeutics Corp's drug to treat an aggressive form of neuroblastoma, a rare cancer that typically occurs in children below 5 years. Wedbush Securities analyst Liana Moussatos estimated there are about 425 high-risk patients in the United States and 1,275 worldwide.

  • March 10- The U.S. Food and Drug Administration said it approved United Therapeutics Corp's drug to treat neuroblastoma, a rare cancer that typically occurs in children below 5 years. Unituxin is the first drug approved to treat high-risk neuroblastoma patients who have a greater chance of tumors recurring or progressing after chemotherapy.

  • March 10- The U.S. Food and Drug Administration said it had approved United Therapeutics Corp's drug to treat neuroblastoma, a rare form of cancer that most often occurs in young children. United Therapeutics' drug, Unituxin, marks the first approval for a therapy aimed at high-risk patients affected by the cancer that forms from immature nerve cells.

  • How many 'life-saving' watches will Apple sell? Monday, 9 Mar 2015 | 1:31 PM ET
    Tim Cook, chief executive officer of Apple Inc., speaks during the Apple Inc. Spring Forward event in San Francisco, California.

    CNBC Pro Preview: Influential technology analyst Toni Sacconaghi said Apple could sell 1 billion watches.

  • March 9- An injection for double chin reduction developed by Kythera Biopharmaceutical Inc was unanimously backed by an independent panel of experts on Monday, bringing the drug a step closer to approval by the U.S. Food and Drug Administration. The FDA typically accepts the panel's recommendations. The drug is widely expected to win approval by May 13, when the...

  • March 9- An injection for double chin reduction, developed by Kythera Biopharmaceutical Inc, was unanimously backed by an independent panel of experts on Monday, bringing the drug a step closer to approval by the U.S. Food and Drug Administration. The drug, ATX-101, is a formulation of deoxycholic acid, which destroys fat cells under the chin but leaves...

  • March 9- AcelRx Pharmaceuticals Inc said the U.S. Food and Drug Administration has sought an additional study on the company's pain drug-device rejected once last year. Shares of AcelRx, which said it would not resubmit the Zalviso's regulatory application this quarter as it needed more clarity from the FDA, were down about 40 percent in premarket trading on...

  • FDA approves Zarxio, first biosimilar drug Friday, 6 Mar 2015 | 1:46 PM ET
    Hypodermic needle filled from vial

    The Food and Drug Administration has approved the first so-called biosimilar drug for use in the United States. The New York Times reports.

  • ReWalk Robotics talks sales   Thursday, 5 Mar 2015 | 2:17 PM ET
    ReWalk Robotics talks sales

    Barclays is saying there is low visibility into ReWalk Robotics. The company's CEO Larry Jasinski, discusses the company's forecast for its ReWalk devices.

  • No safety issues associated with long-term use of ATX-101 have been identified so far, FDA reviewers said on Thursday. An independent panel of experts will meet on Monday to discuss the drug and recommend to the FDA whether it should be approved. Leerink Partners analyst Seamus Fernandez said he expects the drug to be approved by May 13, when the FDA is scheduled...

  • It did recommend that healthcare providers inform patients of the risks, including infection, and benefits associated with the procedure and report to the manufacturer and the FDA if they suspect problems with the equipment have led to patient infections. In a safety alert the same day, the FDA said the complex design of endoscopes linked to the UCLA outbreak...