Drug treatment is a significantly less costly means of treating abnormal uterine bleeding compared with hysterectomy, according to researchers. However, many patients may still eventually have to undergo hysterectomy.
The U.S. Food and Drug Administration today warned several manufacturers and distributors of unapproved drugs containing steroids that continued distribution and sale of these products without FDA approval could result in regulatory action including seizure and injunction. FDA is concerned that the use of these products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.
The Food and Drug Administration (FDA) announced the approval of Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that can not be removed by surgery (unresectable SCCHN). This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Erbitux was also approved today for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy.
The Food and Drug Administration approved Eraxis (anidulafungin) to treat certain infections caused by Candida, a yeast-like fungus that can cause serious infections in hospitalized patients or patients with compromised immune systems.
The Food and Drug Administration (FDA) approved Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug Flonase, giving American consumers an additional, lower cost alternative when choosing prescription drug products.
The Food and Drug Administration approved Emsam (selegiline), the first skin (transdermal) patch for use in treating major depression. The once a day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. At its lowest strength, Emsam can be used without the dietary restrictions that are needed for all oral MAO inhibitors that are approved for treating major depression.
To minimize microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers in a ready-to-eat form, The Food and Drug Administration (FDA) published a draft guidance document for producers of fresh-cut produce entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables.”
The Food and Drug Administration (FDA) issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines. FDA’s goal is to expedite the development and availability of safe and effective vaccines needed to protect against influenza.
The Food and Drug Administration (FDA), the National Cancer Institute (NCI), part of the National Institutes of Health, and the Centers for Medicare & Medicaid Services (CMS) today announced the Oncology Biomarker Qualification Initiative (OBQI) — an agreement to collaborate on improving the development of cancer therapies and the outcomes for cancer patients through biomarker development and evaluation.
Alzheimer’s disease, a leading cause of dementia in the elderly, appears later in highly educated people — but once it does, it advances more quickly, scientists said.