The U.S. Food and Drug Administration (FDA) approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis. A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the [...]
The U.S. Food and Drug Administration approved Xgeva (denosumab) on Thursday to help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation. Xgeva is a monoclonal antibody that targets a protein involved in cancer-related bone destruction [...]
After two days of hearings, the 11 members of the US Food and Drug Administration did not reach a verdict about giving or denying approval to a genetic modification process that could make the salmon grow twice as fast. According to the panel members – all of them outside experts – there is not enough [...]
The FDA announced hat it has approved vaccines for the 2010-2011 influenza season in the United States. Seasonal influenza vaccine protects against three strains of influenza, including the 2009 H1N1 influenza virus, which caused the 2009 pandemic. Last year because the 2009 H1N1 virus emerged after production began on the seasonal vaccine, two separate vaccines [...]
Trafficanda Egg Ranch has announced the voluntary recall of eggs associated with a new Salmonella outbreak in the US. The eggs being recalled were supplied by the Wright County Egg company. The recall affects eggs of different sizes – Medium, Large, X-Large and Jumbo – with specific Julian dates. The eggs with the following Julian [...]
FDA Warning: The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement. TimeOut is labeled as “100% natural” and consumers may mistakenly assume the product is harmless [...]
The U.S. Food and Drug Administration (FDA) advise use of pasteurized shell and liquid eggs to help retailers and consumers, to avoid contracting dangerous egg-related salmonella enteritdis (SE). The FDA recommendation was made amid news of a massive recall of shell eggs and a CDC report that since May 2010, there has been a four-fold [...]
The FDA approved ella (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive. ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. [...]
FDA Warning: The U.S. Food and Drug Administration warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection. The agency is working with the drug’s manufacturer, GlaxoSmithKline, to update [...]
FDA Warning: The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets. Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on [...]