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  • April 10- Swedish Match AB should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes, an advisory panel to the U.S. Food and Drug Administration concluded on Friday.

  • CHICAGO, April 10- Sales of medically important antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators reported on Friday, data that is sure to fuel concern that bacteria infecting humans could grow more resistant to the drugs. The U.S. Food and Drug Administration reported that domestic sales and...

  • WASHINGTON— Government advisers recommended against a proposal by Swedish Match to market its smokeless tobacco pouches as less harmful than cigarettes and other tobacco products. Swedish Match has asked the FDA to drop those warnings from its U.S. offerings, including brands such as Longhorn, Timber Wolf and General snus. Stockholm- based Swedish Match also...

  • NEW YORK— Canadian drugmaker Tekmira Pharmaceuticals said Friday it will restart a study of an experimental Ebola treatment in the coming weeks. The company said the Food and Drug Administration will allow it to administer the drug, called TKM-Ebola, to a small number of healthy people once a day for a one-week safety trial. Shares of Tekmira Pharmaceuticals...

  • U.S. meat industry buying more human antibiotics -FDA Friday, 10 Apr 2015 | 11:39 AM ET

    CHICAGO, April 10- Sales of medically important antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators reported on Friday, data that is sure to feed the national debate about the growth of drug-resistant bacteria. The U.S. Food and Drug Administration reported that domestic sales and distribution...

  • April 10- AstraZeneca Plc's diabetes drug Onglyza may be associated with an increased rate of death, according to a preliminary review of data by the U.S. Food and Drug Administration. The FDA's report, posted on the agency's website on Friday, comes ahead of an April 14 meeting of an FDA advisory panel to discuss the drug's safety. The FDA said the causes of death...

  • Britain's FTSE nears record high as Shire shines Friday, 10 Apr 2015 | 9:11 AM ET

    *FTSE 100 up 0.5 pct, near record highs. The FTSE 100 rose 0.5 percent to 7,051.07 points, close to a record 7,065.08 points reached in March. Shire shares rose 5.2 percent, the biggest gain on the FTSE 100, from a U.S. Food and Drug Administration decision to grant a priority review to its application for lifitegrast, a dry-eye disease treatment.

  • FDA stayed silent on hazardous diet pills: Report Wednesday, 8 Apr 2015 | 11:50 AM ET
    A Vitamin Shoppe store in New York.

    FDA never publicized that popular supplements contain a chemical nearly identical to amphetamine. New York Times reports.

  • Merck's potential HCV drug gets special FDA designation Wednesday, 8 Apr 2015 | 7:26 AM ET

    NEW YORK— Merck& Co. said Wednesday that the Food and Drug Administration granted the pharmaceutical company's developing hepatitis C treatment two special designations. The FDA granted Merck's grazoprevir/elbasvir combination "breakthrough therapy designation" for two different types of the condition, which affects the liver. The Kenilworth, New...

  • 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.

  • 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,...