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FIRST tool kit teaches how to reduce the risks of food contamination
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The U.S. Food and Drug Administration (FDA) yesterday cleared a new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses.
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Biomoda, Inc. (OTC Bulletin Board: BMOD) , a development stage medical diagnostics company, submitted to the FDA a pre-IDE protocol for a clinical study using Biomoda's proprietary assay for detection of early lung cancer in veterans.
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Regulators find dangerous levels of toxins that cause Paralytic Shellfish Poisoning
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Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine.
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The draft guidelines issued today-called an FDA guidance document-outline the agency's recommendations for pre-market clinical evaluation and post-market studies.
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The AIDS Institute, a national public policy research, advocacy, and education organization, is encouraged with the FDA's approval of the first new non-nucleoside reverse transcriptase inhibitor (NNRTI) in nearly a decade.
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The Food and Drug Administration today issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin.
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Bystolic is a beta blocker, a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps.
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he U.S. Food and Drug Administration today approved the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug.
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The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs.
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Following the President's signature of the Food and Drug Administration (FDA) Amendments Act, HHS Secretary Mike Leavitt praised the bill as an important step forward in ensuring the safety of drugs and medical devices.
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The Food and Drug Administration is alerting health care professionals and consumers to concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events.
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The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be especially sensitive to the blood-thinning drug warfarin (Coumadin), which is used to prevent potentially fatal clots in blood vessels.
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The U.S. Food and Drug Administration (FDA) today sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product.
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The U.S. Food and Drug Administration today approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
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Congestive heart failure rarely occurs among leukemia patients who take imatinib, researchers at The University of Texas M. D. Anderson Cancer Center found after an exhaustive review of the detailed medical histories of 1,276 patients who enrolled in clinical trials for the drug.
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Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.
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Eli Lilly and Company (NYSE: LLY) announced today that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to recommend approval of its osteoporosis drug EVISTA® (raloxifene HCl) for a new use to reduce invasive breast cancer risk in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer.
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Roche announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to market Tamiflu(R) (oseltamivir phosphate) capsules in 30 mg and 45 mg doses.
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