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  • FDA study finds little evidence of antibiotics in milk Thursday, 5 Mar 2015 | 2:08 PM ET

    WASHINGTON— In an encouraging development for consumers worried about antibiotics in their milk, a new Food and Drug Administration study showed little evidence of drug contamination after surveying almost 2,000 dairy farms. In response to concerns, the agency in 2012 took samples of raw milk from the farms and tested them for 31 drugs, almost all of them...

  • 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...

  • The FDA confirmed that Olympus Corp. did not seek agency clearance for the redesign of its specialized endoscope, which it began selling in 2010. FDA clearance is required for all substantive updates to medical devices sold in the U.S. Despite the lack of clearance, the FDA said doctors should continue using the device because it's not clear that a federal...

  • 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...

  • FDA approves Bristol-Myers drug for lung cancer Wednesday, 4 Mar 2015 | 2:22 PM ET

    WASHINGTON— The Food and Drug Administration on Wednesday expanded approval of an innovative Bristol-Myers Squibb drug to treat the most common form of lung cancer. The FDA first approved Bristol's drug in December for melanoma, the deadliest form of skin cancer. Evercore ISI analyst Mark Schoenebaum said in an investment note that Opdivo could garner sales...

  • The number of men being prescribed testosterone jumped more than 75 percent, to 2.3 million, between 2009 and 2013. About 70 percent of these patients were between the ages of 40 and 64, the FDA said. AbbVie Inc's AndroGel, one of the most widely-used products, raked in sales of $934 million in 2014. Other products include Endo International Plc's Testim and Eli...

  • FDA warning: men's testosterone drugs overused Tuesday, 3 Mar 2015 | 12:10 PM ET

    Additionally, the FDA cautioned that the drugs may increase the risk of heart attack, stroke and other cardiovascular problems. Drugmakers must add information about that potential risk to their prescribing labels and conduct a long-term study to further examine the issue, the FDA said. The FDA action follows years of industry marketing for new gels, patches...

  • Pacira Pharma slumps after FDA ruling on pain drug Monday, 2 Mar 2015 | 5:08 PM ET

    NEW YORK— Shares of Pacira Pharmaceuticals tumbled Monday after the company said regulators refused to grant a new marketing approval for its post-surgical pain drug Exparel. Pacira Pharmaceuticals wants to market the drug for blocking nerves to relieve pain after surgery, but the Food and Drug Administration did not give it marketing approval.

  • WASHINGTON— One of the nation's leading medical researchers joined the Food and Drug Administration on Monday, taking on the agency's No. 2 leadership job at a critical juncture for prescription drugs, medical devices and tobacco products. Robert Califf comes to the job of FDA deputy commissioner after more than 30 years as a researcher and administrator at...

  • March 2- The U.S. Food and Drug Administration rejected Pacira Pharmaceuticals Inc's application for expanding the use of its post-surgery pain drug, Exparel. Pacira said on Monday it would work with the FDA to secure the new indication for Exparel, which will allow it to harness a wider range of post-operative patients. Exparel, approved in April 2012 for...

  • March 2- The U.S. Food and Drug Administration rejected Pacira Pharmaceuticals Inc's application for expanding the use of its pain drug, exparel.

  • The scopes were linked to the exposure of 179 patients to drug-resistant bacteria at UCLA's Ronald Reagan Medical Center in Los Angeles and may have contributed to two deaths. In early 2014, following a superbug outbreak at a hospital in Illinois, the FDA asked Fujifilm Holdings Corp, Olympus Corp and Pentax, which make the devices, to submit their test results...

  • Dublin- based Actavis Plc holds the commercial license for the product, but the marketing application was submitted by non-profit pharmaceutical company Medicines360, which holds the U.S. public sector clinic rights. The companies expect the device, which also helps to check heavy menstrual bleeding, to be available in the United States by the second quarter...

  • Actavis Plc holds the commercial license to the device, Liletta. Actavis and Medicines360 expect the device to be available for use in the United States by the second quarter of 2015.. The Actavis device will compete in the $1 billion global market for UIDs, said Michael WaterHouse, an analyst at brokerage Morningstar.

  • Actavis' contraceptive device wins U.S. FDA approval Friday, 27 Feb 2015 | 8:10 AM ET

    Feb 27- The U.S. Food and Drug Administration said on Friday it approved a hormonal contraceptive device, providing American women another reversible contraceptive choice as effective as sterilization. Actavis Plc holds the commercial license to the device, the marketing application of which was submitted by non-profit pharmaceutical company...

  • Feb 25- The U.S. Food and Drug Administration on Wednesday approved the use of Actavis Plc's antibiotic, Avycaz, to battle drug-resistant bacteria known as superbugs. Although a number of companies including Roche Holdings AG, Tetraphase Pharmaceuticals Inc, Achaogen Inc and Cempra Inc, are developing drugs for a variety of superbugs, Gabelli& Co analyst Kevin...

  • Feb 26- Diagnostics company Corgenix Medical Corp said on Thursday U.S. health regulators had approved its rapid Ebola test for emergency use, in response to the world's worst outbreak of the virus that killed more than 10,000 so far. The company's ReEBOV Antigen Rapid Test, which involves putting a drop of blood on a paper strip and waiting for at least 15 minutes...

  • FDA approves Corgenix's Ebola test for emergency use Thursday, 26 Feb 2015 | 9:34 AM ET

    Feb 26- Corgenix Medical Corp said on Thursday the U.S. Food and Drug Administration approved its Ebola test for emergency use. The company's so-called ReEBOV Antigen Rapid Test involves putting a drop of blood on a small paper strip and waiting for 15-25 minutes for a reaction. The test is able to correctly identify about 92 percent of Ebola-infected patients...

  • UPDATE 1-Actavis' superbug antibiotic gets U.S. approval Wednesday, 25 Feb 2015 | 7:50 PM ET

    Feb 25- The U.S. Food and Drug Administration on Wednesday approved the use of Actavis Plc's antibiotic, Avycaz, to battle drug-resistant bacteria known as superbugs. Although a number of companies including Roche Holdings AG, Tetraphase Pharmaceuticals Inc, Achaogen Inc and Cempra Inc, are developing drugs for a variety of superbugs, Gabelli& Co analyst Kevin...

  • FDA approves new antibiotic combo from Actavis Wednesday, 25 Feb 2015 | 6:02 PM ET

    The drug from Actavis PLC contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria. The Food and Drug Administration approved Avycaz to treat certain abdominal infections, in combination with another drug, and for complicated urinary-tract infections, including kidney infections, for which there are...