Science and Enterprise

Tag: FDA

  • Disposable Insulin Device Gets FDA Clearance

    Valeritas Inc., a medical technology company in Bridgewater, New Jersey, says that the US Food and Drug Administration (FDA) has granted 510(k) clearance to the company’s V-Go disposable insulin delivery device. The company designed V-Go for the subcutaneous delivery of insulin in preset basal (low continuous) rates and with on-demand bolus (high volume) dosing for…

  • Bone Graft Substitute Receives FDA Clearance

    Orthovita Inc., an orthobiologics and biosurgery device developer in Malvern, Pennsylvania, says it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Vitoss Bioactive Foam-2X bone graft substitute as a non-structural bone void filler for use in the spine, pelvis, and extremities. The company says it expects to launch the…

  • Engineers Reduce Radiation to Kill Pathogens on Produce

    A team of engineers with the Texas AgriLife Extension Service in College Station has developed a way to cut by as much as half the amount of irradiation needed to kill 99.999 percent of salmonella, E. coli, and other pathogens on fresh produce. By packing produce in a Mylar (polyester plastic) bag filled with pure…

  • Fraunhofer USA Gets FDA Go-Ahead for H5N1 Vaccine Trial

    Fraunhofer USA Center for Molecular Biotechnology (CMB) in Newark, Delaware says it received approval from the U.S. Food and Drug Administration (FDA) to proceed with the first human clinical trial of its plant-produced H5N1 influenza — avian flu — vaccine. The research institute filed an Investigational New Drug Application for its plant-derived H5N1 vaccine with…

  • FDA Approves Two-Minute IV for Superbug Skin Complications

    Cubist Pharmaceuticals Inc. in Lexington, Massachusetts says that its currently-marketed antibiotic Cubicin (daptomycin for injection) has been approved by the U.S. Food & Drug Administration (FDA) for once-a-day dosing as a 2-minute intravenous (IV) injection. The company says Cubicin is the only approved 2-minute IV injection for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) complicated…

  • Study: Pediatric Drug Labeling Tough to Understand

    Instructions on over-the-counter (OTC) medicines for children in the U.S. are confusing and hard for parents to understand and follow, according to a study in the 1 December issue of the Journal of the American Medical Association (JAMA). Researchers at New York University’s School of Medicine, Emory University School of Medicine in Atlanta, University of…

  • Life Science Firms: FDA Improving but Still Not There

    A survey of 50 life science companies conducted by the consulting firm PriceWaterhouseCoopers says the companies feel they have better working relationships with the U.S. Food and Drug Administration (FDA), but they say the agency still does not have adequate resources or is up to speed on advancing technology. The survey was sent electronically to…

  • FDA Clears Protein Test for Heart Failure Prognosis

    BG Medicine Inc., a Waltham, Massacusetts developer of molecular diagnostics using biomarkers, says that the U.S. Food and Drug Administration (FDA) has cleared the company’s galectin-3 test to help assess the prognosis of patients diagnosed with chronic heart failure. The company says this 510(k) clearance is the first time FDA has cleared a test to…

  • FDA Approves 3-D Digital Mammography System

    Hologic Inc., a developer of medical diagnostics and imaging products for women’s health care in Bedford, Massachusetts, says it has received an approval letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions three-dimensional digital mammography tomosynthesis system. The Selenia Dimensions 3-D system is a new method for breast cancer screening and…

  • FDA Approves Drug for Cancer-Related Bone Deterioration

    Amgen Inc., a biotechnology company in Thousand Oaks, California, said the U.S. Food and Drug Administration (FDA) has approved its drug XGEVA (denosumab), for the prevention of skeletal-related events in patients with bone cancers from solid tumors. The company says FDA approved XGEVA following a 6 month priority review by the FDA, a process reserved…