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  • March 27- The United States Food and Drug Administration rejected Adamis Pharmaceuticals Corp's injection for treating severe allergic reactions, the company said. Adamis Pharmaceuticals shares were down 37 percent at $3.40 in after-market trading. The FDA raised questions related to the volume of dose delivered by the pre-filled syringe, Adamis said on...

  • March 27- The United States Food and Drug Administration rejected Adamis Pharmaceuticals Corp's injection for treating severe allergic reactions, the company said on Friday. Adamis said the questions raised by the FDA largely pertained to the volume of the dose delivered by the pre-filled injection. The company said it would meet with the FDA to discuss the...

  • NEW YORK, March 26- Olympus Corp, the largest maker of a medical device at the center of recent U.S. superbug outbreaks, issued new cleaning instructions for its equipment on Thursday, urging health providers to adopt them "as soon as possible." The U.S. Food and Drug Administration does not recommend that patients forego procedures until the brushes are shipped out,...

  • FDA to scrutinize unproven alternative remedies Thursday, 26 Mar 2015 | 10:23 AM ET

    The Food and Drug Administration says that it will hold a two-day meeting next month on regulations for homeopathic medicines, which have long occupied a place on the fringes of U.S. health care. According to a federal notice published online Thursday, the FDA will ask attendees whether there is data to "better assess the risks and benefits" of homeopathic...

  • FDA approves new drug for anthrax poisoning Wednesday, 25 Mar 2015 | 10:43 AM ET

    The Food and Drug Administration approved Anthrasil for use in combination with older antibiotics to treat inhalation anthrax, which can cause serious injury and death. The drug's development was funded by the U.S. government's Biomedical Advanced Research and Development Authority, which stockpiles vaccines, drugs and equipment for use during...

  • March 25- Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the Department of Health and Human Services. Emergent Bio developed the treatment, Anthrasil, as part of a $160 million contract it signed in 2005 with the Biomedical Advanced Research and...

  • March 25- Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the U.S. Department of Health and Human Services. Emergent Bio developed the treatment, Anthrasil, as part of a $160 million contract it signed in 2005 with the Biomedical Advanced Research...

  • FDA approves Emergent BioSolutions' anthrax treatment Wednesday, 25 Mar 2015 | 7:15 AM ET

    March 25- Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the U.S. Department of Health and Human Services.

  • FDA to evaluate homeopathy regulatory framework Tuesday, 24 Mar 2015 | 2:31 PM ET

    March 24- The U.S. Food and Drug Administration said it would hold a public hearing seeking information and comment on the use of products labeled' homeopathic', as well as the agency's regulatory framework for such products. The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the...

  • UPDATE 1-FDA approves Abiomed's blood pump device Monday, 23 Mar 2015 | 6:16 PM ET

    March 23- The U.S. Food and Drug Administration said it approved Abiomed Inc's miniature blood pump system that maintains heart function and circulation during high-risk procedures. Angioplasty and stenting are procedures used to re-open arteries in the heart that are blocked due to coronary artery disease, a condition that is the leading cause of death in...

  • FDA approves Abiomed's blood pump device Monday, 23 Mar 2015 | 5:51 PM ET

    March 23- The U.S. Food and Drug Administration said it approved Abiomed Inc's miniature blood pump system that maintains heart function and circulation during high-risk procedures. The device, Impella 2.5 System, can be used during angioplasty and stenting, the regulator said on Monday. Angioplasty and stenting are procedures used to re-open arteries in the...

  • March 23- The U.S. Food and Drug Administration said it would not recommend changes to the prescribing or use of Eli Lilly and Co's schizophrenia drug after a review of two deaths. The FDA said its investigation into the deaths was inconclusive. It carries a boxed warning, FDA's most serious type of warning, for post-injection delirium sedation or olanzapine...

  • March 23- The U.S. Food and Drug Administration said it would not recommend changes to the prescribing or use of Eli Lilly and Co's schizophrenia drug after a review of two deaths. Elevated levels of the drug, Zyprexa Relprevv, were found in the two patients who died three to four days after receiving the injection. The FDA said its investigation into the deaths was...

  • March 23- Pfizer Inc and Eli Lilly and Co will resume a late-stage study testing their pain drug tanezumab after the U.S. Food and Drug Administration lifted a partial hold on it. Pfizer expects to receive a $200 million upfront payment from Lilly as a result of the development, the companies said on Monday. In 2013, Pfizer forged a deal with Lilly to jointly develop...

  • March 23- Pfizer Inc and Eli Lilly and Co said they planned to resume a late-stage study testing their pain drug tanezumab after the U.S. Food and Drug Administration lifted a partial hold on it. Pfizer expects to receive a $200 million upfront payment from Lilly as a result of the development, the companies said on Monday. The FDA put tanezumab and all other...

  • BOISE, Idaho— Potatoes that won't bruise and apples that won't brown are a step closer to grocery store aisles. The Food and Drug Administration on Friday approved the genetically engineered foods, saying they are "as safe and nutritious as their conventional counterparts." The approval covers six varieties of potatoes by Boise, Idaho- based J. R. Simplot Co. and two...

  • March 19- GlaxoSmithKline Plc's drug to treat chronic breathing problems is safe and effective enough to be approved in adults with asthma, but not adolescents, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. The FDA is not obliged to follow the advice of its advisory panels but typically does so. Glaxo licensed the product from...

  • The FDA is not required to follow the recommendations of its experts, though it often does. Breo Ellipta is already approved in the U.S. for a type of chronic lung disease, but Glaxo is hoping to expand the drug's use to the much larger patient population of roughly 37 million Americans with asthma. In 2010, FDA required manufacturers of LABA-steroid combination...

  • Amicus to seek Fabry disease drug approval Thursday, 19 Mar 2015 | 12:46 PM ET

    CRANBURY, N.J.— Amicus Therapeutics plans to file for accelerated approval of its experimental treatment for a rare, inherited disease following meetings with regulators in the U.S. and Europe. In the U.S., the company plans to file for approval of the drug, called migalastat, with the Food and Drug Administration in the second half of the year, while it plans on...

  • FDA panel to discuss Ebola vaccine development in May Wednesday, 18 Mar 2015 | 8:16 AM ET

    March 18- The U.S. Food and Drug Administration said an advisory panel will discuss the development of Ebola vaccines, days after an American health worker was flown back after being tested positive for Ebola in Sierra Leone. Ebola has so far claimed about 10,000 lives in Sierra Leone, Liberia and Guinea. Other companies that are testing potential treatments for...