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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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The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.
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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 U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product.
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The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery.
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The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.
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Company manufactures and distributes unapproved and adulterated drugs
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The U.S. Food and Drug Administration today delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.
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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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Wal-Mart announced that the FDA's most recent prescription to over-the-counter (OTC) approved drug, Zyrtec® (cetirizine HCl) is now available at select Wal-Mart U.S. stores.
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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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The U.S. Food and Drug Administration (FDA) has approved raltegravir tablets for treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
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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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