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  • GE's 3D mammography device gets U.S. FDA approval Tuesday, 2 Sep 2014 | 9:34 PM ET

    Sept 2- General Electric Co's healthcare unit last week won U.S. Food and Drug Administration approval for its mammography device that produces three-dimensional images to detect breast cancer. Hologic Inc came up with one of the first 3- D breast imaging devices in 2001, which continues to dominate the market.

  • Aug 28- OncoMed Pharmaceuticals Inc said the U.S. Food and Drug Administration lifted a partial hold on patient enrolments for three trials testing its experimental cancer drug, vantictumab.

  • Aug 28- Johnson& Johnson is recalling some lots of its implant used to correct defects of the jaw, following more than a dozen cases of injury.

  • Aug 28- OncoMed Pharmaceuticals Inc said the U.S. Food and Drug Administration lifted a partial hold on patient enrolments for three trials testing its experimental cancer drug, vantictumab. OncoMed is developing the drug in collaboration with Germany's Bayer AG. The FDA formally placed a partial hold on vantictumab, following the voluntary halt.

  • FDA says Johnson & Johnson recalls some jaw implants Thursday, 28 Aug 2014 | 8:17 AM ET

    Aug 28- Johnson& Johnson is recalling some lots of its implant used to correct defects of the jaw following more than a dozen cases of injury. The device, which is used to lengthen and stabilize the lower jawbone and the side of the lower jaw, is being recalled by JNJ unit DePuy Synthes as it may reverse after surgery.

  • FDA investigating large Maine lobster processor Wednesday, 27 Aug 2014 | 9:16 AM ET

    The FDA in February sent a letter to Rockland- based Linda Bean's citing the firm for "significant violations" in the way it processed seafood. Linda Bean, owner and namesake of the firm, said in an email to The Associated Press that she has "addressed everything" and added the FDA's letter of violations was "reasonable.

  • FDA names potential Insys treatment an orphan drug Monday, 25 Aug 2014 | 10:17 AM ET

    A potential treatment from Insys Therapeutics Inc. for an aggressive form of brain cancer will have some marketing exclusivity if regulators eventually approve it. The Food and Drug Administration has granted an orphan drug designation to the Chandler, Arizona, drugmaker's pharmaceutical cannabidiol, or CBD.

  • Aug 25- Regado Biosciences Inc said it stopped enrollment in a late-stage trial of its lead drug after an independent safety panel raised serious concerns of allergic reactions, sending the company's shares down about 26 percent before the bell. The U.S. Food and Drug Administration also imposed a clinical hold on the trial.

  • FDA clears Eliquis for new use against blood clots Thursday, 21 Aug 2014 | 3:10 PM ET

    WASHINGTON— Bristol-Myers Squibb and Pfizer said Thursday that federal regulators have expanded approval of their blood thinner Eliquis to treat two types of dangerous blood clots. The Food and Drug Administration cleared the drug for patients suffering from or at risk of deep vein thrombosis and pulmonary embolism.

  • Aug 15- Acura Pharmaceuticals Inc said the U.S. Food and Drug Administration indicated that the company may have to conduct an additional study to determine the abuse-deterrent capability of its experimental painkiller treatment. The FDA in May said data was insufficient to support the company's claim that the drug could not be abused by snorting.

  • AG Zoeller urges FDA to regulate e-cigs     Monday, 11 Aug 2014 | 10:44 AM ET

    Indiana Attorney General Greg Zoeller, has joined the fight to urge the FDA to strengthen electronic cigarette regulations and adopt new policies to protect minors from harmful flavoring and addictive electronic cigarettes.

  • Aug 8- Shares of Canada's Tekmira Pharmaceutical Corp jumped as much as 25 percent in early trading on Friday, after a regulator cleared its experimental Ebola drug for potential use in humans infected with the virus.

  • Aug 7- Tekmira Pharmaceutical Corp said on Thursday that the U.S. Food and Drug Administration had modified its clinical hold status on Tekmira's experimental Ebola treatment to enable its potential use in humans infected with the virus.

  • Aug 7- Tekmira Pharmaceutical Corp said on Thursday that the U.S. Food and Drug Administration had modified its clinical hold status on Tekmira's experimental Ebola treatment to enable its potential use in humans infected with the virus.

  • *Cuts top end of FY earnings forecast to $3.45/ shr from $3.60/ shr. Aug 7- Mylan Inc shaved the top end of its full-year revenue and earnings forecasts, citing delays in approval from the U.S. Food and Drug Administration for key generic drugs that it plans to launch this year.

  • Clearing FDA hurdles     Thursday, 7 Aug 2014 | 6:51 AM ET

    Scott Gottlieb, M.D., American Enterprise Institute, explains why he thinks excessive FDA regulations are stalling innovation in medical technology.

  • Mylan narrows full-year revenue, profit forecast Thursday, 7 Aug 2014 | 6:48 AM ET

    Aug 7- Generic drug maker Mylan Inc narrowed its full-year revenue and earnings forecast, citing delays in U.S. Food and Drug Administration approval of key products. The company narrowed its revenue forecast range to $7.8 billion- $8 billion from $7.8 billion- $8.2 billion.

  • Gaining access to experimental drugs     Tuesday, 5 Aug 2014 | 7:44 AM ET

    Scott Gottlieb, M.D., American Enterprise Institute, and Jeff Allen, Friends of Cancer Research executive director, discuss the FDA's drug approval process and the need in some cases to allow access to experimental therapies.

  • Why dying kids can't get the drugs they need Tuesday, 5 Aug 2014 | 7:33 AM ET
    Nathalie Traller back in the clinic.

    Terminally ill patients are increasingly seeking access experimental drugs outside clinical trials, but drug companies often decline these requests. A look at why.

  • A senior official within FDA told Reuters the agency would consider proposals for providing treatments under special emergency new drug applications, if the benefits of the treatment outweighed the potential safety risks. The hold prompted a North Carolina physician with family members in West Africa to say enough.