Test That May Expedite Patient Therapy Receives FDA Approval
The Food and Drug Administration has given its approval to a test that is supposed to allow for more expedient testing procedures that should enable doctors to treat patients suffering from illnesses related to yeast or bacteria more quickly. The new mass spectrometer system, which goes by the name VITEK MS, is purported to be… read more
FDA Developing Framework For Medical App Regulation
The burgeoning nature of the medical app industry is something that no one could have predicted ten years ago. As more and more hospitals and doctors across the country begin to adopt apps for a variety of purposes, the Food and Drug Administration is trying to come to terms with these new innovations and develop… read more
FDA Mulls The Fate of Suvorexant From Merck
Today, the Food and Drug Administration will convene an expert panel to offer recommendations about a new insomnia drug from Merck. The company is seeking the approval of suvorexant, which is designed to help people suffering from insomnia fall asleep. In preparation for today’s meeting, the FDA has made their concerns about the drug known… read more
Debate Rages Over the Safety of Genetically Modified Salmon
The word Frankenfish probably doesn’t conjure up images of something that you would want on your seafood platter. This somewhat derogatory term has been bestowed upon a type of salmon that has been genetically modified by scientists. Specifically, a company called AquaBounty has added a couple genes from other fish to make the salmon grow… read more
FDA Might Reclassify Automated External Defibrillators
Before 2012 is out, the Food and Drug Administration will likely decide whether or not automated external defibrillators should be designated as a Class III medical device, which would mean that the items would be considered high-risk and required to conform to more stringent approval procedures. Previously, a grandfather clause allowed such devices to maintain… read more
FDA Denies Approval of Lixivaptan, Citing Need for More Information
Lixivaptan will not be approved until the Food and Drug Administration is able to see more data in regards to the drug. Cornerstone Therapeutics is the company behind the drug, which is meant to treat a condition known as hyponatremia. This condition is what happens when a person’s blood does not have enough sodium. An… read more
300 MG Budeprion XL No Longer Approved by FDA
300 milligram tablets of Budeprion XL have lost their approval from the Food and Drug Administration following testing which suggested the key ingredient in this drug was not being adequately distributed in the bloodstream. This generic counterpart to the Wellbutrin XL antidepressant allegedly distributes the active ingredient quicker than Wellbutrin proper, and many people have… read more
Eliquis Approval Delayed Until More Drug Trial Information is Given
A blood thinner that could benefit those suffering from a certain heart condition has had its approval delayed for the time being by the Food and Drug Administration. The drug in question is Eliquis, which is jointly produced by Pfizer and Bristol-Myers Squibb. The drug aims to reduce the risk of blood clots which lead… read more
FDA Worried About Efficacy and Safety of Carfilzomib Cancer Treatment
The Food and Drug Administration has expressed concerns that a drug seeking approval might be more trouble than it’s worth. The drug being considered for approval is known as carfilzomib. Its makers, Onyx Pharmaceuticals, were hoping that they could get the drug approved for the treatment of multiple myeloma, a rare type of cancer that… read more
Outlook Not Good on FDA Approval of Semuloparin Blood Thinner
The Food and Drug Administration needs more information before they can approve a new drug for the prevention of blood clots in individuals who are in the process of undergoing chemotherapy. The drug being considered is a blood thinner known as semuloparin. Produced by the Paris-based Sanofi, it was hoped by the company that the… read more
FDA To Allow Early Onset Testing of Breast Cancer Drugs
Women suffering from a certain type of aggressive breast cancer are going to be able to get their hands on new drugs faster than would have previously been possible. That’s because the Food and Drug Administration released a guidance document recently that allows various drug companies to test new drugs on women with a specific… read more
FDA Denies Bid to Get High Fructose Corn Syrup Renamed
The Food and Drug Administration has opted not to allow the makers of high fructose corn syrup to change the name of the product. The Corn Refiners Association was hoping to get high fructose corn syrup’s name changed to the more pleasant-sounding “corn sugar.” They petitioned the FDA way back in 2010, and justified the… read more
