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  • April 30- The U.S. Food and Drug Administration on Thursday approved The Medicines Co's dry powder blood-clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The approval comes at a time Medicines Co is facing a drop in sales of its lead product, Angiomax anticoagulant injection, which accounted for over 80...

  • FDA approves Medicines Co's blood clotting agent Thursday, 30 Apr 2015 | 5:47 PM ET

    April 30- The U. S Food and Drug Administration approved the Medicines Co's dry powder blood clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The treatment, Raplixa, is a combination of two human plasma-derived blood-clotting proteins, fibrinogen and thrombin. Raplixa is used to control bleeding during...

  • Glaxo gets OK to expand marketing of inhaler drug Thursday, 30 Apr 2015 | 3:46 PM ET

    WASHINGTON— GlaxoSmithKline plc says it has received U.S. approval to sell its once-a-day respiratory inhaler Breo Ellipta for a new use in asthma patients ages 18 and older. The expanded approval from the Food and Drug Administration will help Glaxo replace sales of its best-selling product, Advair, which faces generic competition in Europe and pricing...

  • Since the review of healthcare antiseptics in the 1970' s, things have changed, the FDA noted, alluding to a shift in frequency of use, a hospital's infection control practices, technology and safety standards. The regulator is looking to play catch up with the scientific community after an independent panel of experts to the FDA raised similar concerns last year.

  • FDA seeks more data on antiseptic ingredients Thursday, 30 Apr 2015 | 10:49 AM ET

    Alcohol and iodines are the most common active ingredients in such antiseptics, the FDA said, adding that home-use antiseptics such as antibacterial soap and hand sanitizers are not part of this evaluation. Accordingly, the FDA is requesting more data on absorption, potential hormonal effects and bacterial resistance of antiseptics under the...

  • FDA seeks more data on safety of hospital hand cleaners Thursday, 30 Apr 2015 | 8:52 AM ET

    For now, the FDA stressed that health care workers should continue using hand washes, sanitizers and surgical scrubs, which are standard tools for preventing health care infections. "We're not asking for any of these products to come off the market at this time, we're just asking for additional data," Theresa Michele, a director in the agency's drug center, said in an...

  • April 29- Amgen Inc's skin cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval, an independent advisory panel to the U.S. Food and Drug Administration said on Wednesday. Amgen said on Wednesday that T-Vec was more effective in melanoma patients whose cancer had not spread to internal organs.

  • April 29- Amgen Inc's skin cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval, an independent advisory panel to the U.S. Food and Drug Administration said on Wednesday. The panel voted 22-1 supporting an approval for the therapy, talimogene laherparepvec or "T-Vec", an engineered virus that kills cancer...

  • FDA approves injection for melting away double-chin fat Wednesday, 29 Apr 2015 | 4:26 PM ET

    NEW YORK— The Food and Drug Administration said Wednesday it approved an injection designed to melt away double-chin fat. It's the first approved drug for Kythera Biopharmaceuticals. The drug is a synthetic form of deoxycholic acid, a chemical the FDA said is naturally produced by the body and helps it absorb fats.

  • April 29- The U.S. Food and Drug Administration said on Wednesday it approved an injection for "double chin" reduction, developed by Kythera Biopharmaceuticals Inc.. Submental, or below the chin, liposuction costs between $2,700 and $5,175, according to the American Society for Dermatologic Surgery. Last year, Kythera regained the rights to market the drug...

  • FDA approves generic versions of schizophrenia drug Tuesday, 28 Apr 2015 | 5:26 PM ET

    WASHINGTON— The Food and Drug Administration said Tuesday it has approved the first generic versions of Abilify, the blockbuster pill used to treat schizophrenia and bipolar disorder. The agency approved generic versions of the drug from four companies: Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd....

  • The FDA said it considered Velocity adulterated because there is not enough information to provide reasonable assurance that DMBA is safe. The FDA actions come amid pressure from lawmakers and a Harvard University academic, Dr. "Rather than waiting until heart attacks, strokes or deaths are definitely linked to this new designer stimulant, the FDA has now made...

  • April 27- Medtronic Plc has agreed to resolve U.S. regulators' allegations it violated quality standards for making its SynchroMed implantable infusion pump, which delivers medications to cancer patients and others with chronic pain. The agreement includes Medtronic Chief Executive Omar Ishrak and Senior Vice President Thomas Tefft.

  • WASHINGTON— The Food and Drug Administration says Medtronic must stop most sales of its implantable drug pumps after years of uncorrected problems. The FDA has filed a court order against Medtronic that says the medical device giant must halt most production and distribution of its Synchromed II drug pumps, which are implanted devices used to treat patients...

  • April 27- Medical device maker Medtronic Plc said it reached a settlement agreement with the U.S. Food and Drug Administration over one of the company's drug delivery systems. The consent decree places some restrictions on the company and outlines the steps it must take to address the FDA's expectations, the company said on Monday. The agreement does not...

  • *Amgen's fall drags downs biotech stocks. Amgen shares dropped 3.2 percent to $162.53 after U.S. Food and Drug Administration staff reviewers said Amgen's skin cancer immunotherapy cannot be considered for an accelerated review at this time, citing concerns over the design and results of a key study. The healthcare sector is being dragged down by reports on...

  • *FDA cites concerns over late-stage study design, results. April 27- U.S. Food and Drug Administration staff reviewers said an accelerated review of drugmaker Amgen Inc's skin cancer immunotherapy cannot be considered at this time, citing concerns over the design and results of a key study. T-Vec represents a new class of agent for the treatment of metastatic...

  • April 27- The U.S. Food and Drug Administration should not consider an accelerated review of Amgen Inc's marketing application for its skin cancer vaccine, FDA staff reviewers concluded in documents released on Monday, citing concerns over the design and results of a key study. The review comes two days before a panel of FDA advisers votes on whether the...

  • April 27- The U.S. Food and Drug Administration should not consider an accelerated review for drugmaker Amgen Inc's marketing application for its skin cancer vaccine, FDA staff reviewers concluded in documents released on Monday. The review comes two days before a panel of FDA advisers votes on whether the treatment, a cancer-killing virus called talimogene...

  • The Denver- based chain had already been using mostly non-GMO ingredients, but was working on making final changes to its tortillas. The Food and Drug Administration maintains that GMOs are safe, and most of the country's corn and soybean crops are genetically modified to have certain traits like resistance to herbicides and plant diseases.