Bleeding rates linked to new use of Pradaxa (Dabigatran) are no higher than they are with new users of warfarin, says a new FDA Drug Safety communication report update (November 2, 2012). The FDA (Food and Drug Administration) carried out an evaluation on Pradaxa after receiving several...
The New England Compounding Center (NECC) facility has problems maintaining its clean rooms, the Food and Drug Administration (FDA) informed as it released a copy of the FDA Form 483 to the NECC. The FDA says it listed a number of "observations", including contaminated products. FDA inspectors...
As the number of victims of a deadly*meningitis*outbreak grows, the FDA and CDC have been scrambling to educate the public about the steroid shots that they believed to be the source. Now, the FDA has announced that indeed, the fungus from the shots is the same fungus that has appeared in...
Neti pots are little teapot-like devices which people use to rinse out their sinuses. The Food and Drug Administration (FDA) warns that if they are not used properly, the user runs a risk of developing serious infections, even potentially fatal ones. The FDA says that the neti pots are not the...
Today in junk food products that try to disguise themselves as healthy: Hershey's chocolate syrup. In February, the FDA sent a warning letter to the CEO and President of Hershey Co.,*John P. Bilbrey. The letter advised Mr. Bilbrey that the front-of-package labeling of some of his company's...
23andMe, a company that makes personalized DNA tests, has asked the Food and Drug Administration to approve their kits for at-home use. Scientists and medical professionals are skeptical about the kits, which they say don't give accurate results about risk factors for diseases and other health...
TGF-β2 inhibitor has gained market exclusivity in the USA for a third aggressive cancer indication The biopharmaceutical company Antisense Pharma GmbH announces that the US Food and Drug Administration (FDA) has granted Orphan Drug designation for its investigational oncology antisense...
The FDA has finally*approved a new drug that prevents HIV infection. The medicine, Truvada, is a daily pill expected to be taken by people at a high-risk of becoming infected with HIV (gay and bisexual men usually, but the drug has been approved for all HIV-negative people). This is awesome news...
Yesterday, the FDA finally granted approval to*OraQuick,*the first-ever at-home HIV test. The test, which the New York Times calls "as easy as a home-pregnancy test" would make it super-simple to get tested and diagnosed, right in the privacy of your own home. Which is huge for stopping the...
The US Food and Drug Administration (FDA) announced on Tuesday that is has approved the first over the counter HIV test kit that allows Americans to test, in the privacy of their own homes, whether they are infected with the virus that causes AIDS. The OraQuick In-Home HIV Test detects the...
The FDA just approved Belviq, the first weight loss drug to get their green light in 13 years. The agency claims that its safety standards were set high (because of weight loss drugs' sketchy history), but it's hard to shake the feeling that their approval was made in the best interest of public...
The US Food and Drug (FDA) announced on Wednesday that it has approved the weight loss pill Belviq, for use in adults who are obese or overweight, as part of chronic weight management that includes a reduced calorie diet and exercise. Belviq (lorcaserin hydrochloride), made by the Swiss pharma...
The Food and Drug Administration has approved a new test to help physicians diagnose a group of rare cell disorders. The test, or assay, was developed by an expert at Virginia Commonwealth University in the field of mast cells. Lawrence Schwartz, M.D., Ph.D., chair of the Division of...
FDA has issued an alert to healthcare professionals and those suffering from multiple sclerosis. An avante garde procedure used to treat suffers of chronic cerebrospinal venous insufficiency (CCSVI), has been deemed unsafe, causing potential injury and even death. The procedure, known as...
On Thursday, a panel of outside experts that advises the US Food and Drug Administration (FDA) voted to support approval of the daily pill Truvada to prevent HIV in healthy people. The FDA is not obliged to follow the advice of its Antiviral Drugs Advisory Committee, but should it do so, then...
Lorcaserin, an investigational obesity drug, was given a positive recommendation by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the Food and Drug Administration (FDA). The Committee voted 18 to 4 in favor, with one abstention, in advising the FDA whether to approve...
Good news: The U.S. Food and Drug Administration announced that they are calling on our nation's pork, beef, and poultry farmers to reduce the use of antibiotics in these animals. Bad news: Some watchdog groups say this recommendation doesn't go far enough. And worse yet: The real reason these...
The U.S. Food and Drug Administration has approved Korlym (mifepristone) to control hyperglycemia (high blood sugar levels) in adults with endogenous Cushing's syndrome, who have type 2 diabetes or glucose intolerance, who remained unresponsive to previous surgery or are not eligible candidates...