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  • April 7- Denmark's Novo Nordisk A/S said the U.S. Food and Drug Administration accepted a resubmitted application for its key insulin drug, Tresiba, based on interim analysis data from a clinical trial. Tresiba, already available outside the United States, was rebuffed by the FDA two years ago on concerns that the drug could be linked to higher rates of heart...

  • April 7- Denmark's Novo Nordisk said the U.S. Food and Drug Administration accepted a resubmitted application for its insulin drug, Tresiba.

  • April 7- Hospira Inc, which agreed in February to be bought by Pfizer Inc, said the U.S. Food and Drug Administration had sent it another warning letter detailing violations in standard drug manufacturing practices at one of its facilities. Hospira's response to the FDA's concerns lacked "sufficient corrective actions", the agency said. However, the FDA warned in...

  • WASHINGTON, April 7- The U.S. Food and Drug Administration said on Tuesday it is concerned that a Swedish Match AB proposal to soften warnings on its snus smokeless tobacco products would not accurately reflect the risks associated with snus use. Stockholm- based Swedish Match is seeking FDA approval of language stating that its snus products are less risky...

  • Hospira gets FDA warning letter for Italian facility Tuesday, 7 Apr 2015 | 11:12 AM ET

    April 7- Hospira Inc, which agreed in February to be acquired by Pfizer Inc, said it received a warning letter from the U.S. Food and Drug Administration related to its manufacturing facility in Liscate, Italy.

  • April 6- Ocular Therapeutix Inc said its lead eye drug failed to meet one of the main goals in a second late-stage study. Both endpoints needed to be met for the trial to be considered successful, Ocular Therapeutix said. The company said it plans to meet the U.S. Food and Drug Administration to discuss the trial results.

  • Online breast milk may not be 100% human milk Monday, 6 Apr 2015 | 10:20 AM ET
    A previous study conducted by Nationwide Children's Hospital found that of the 102 samples they bought and tested, 75 percent were contaminated with disease-causing bacteria.

    NBC News reports on a study that finds some breast milk sold online actually contains cow's milk.

  • WASHINGTON, April 2- In a decision that could reshape U.S. tobacco regulation, a health advisory panel will vote next week on whether Swedish Match AB, a Stockholm- based maker of smokeless tobacco products known as snus, can claim they are less harmful than cigarettes. The closely watched vote could pave the way for the first Food and Drug Administration approval...

  • LONDON, April 1- A European project to streamline drug approvals moves up a gear next week when regulators sit down with the first company to have an experimental product assessed under a new flexible pilot scheme. In the United States, the Food and Drug Administration has introduced a successful "breakthrough" designation, which has speeded up approval of...

  • 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,...

  • 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...