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The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality).
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel and Charles LeBlanc Fisheries Ltd., CAP-PELE, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product.
Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls
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