Kratom Association Calls FDA Review of Drug 'Junk Science' in Scathing Report

Kratom Association Calls FDA Review of Drug 'Junk Science' in Scathing Report

Earlier this year, the FDA announced that kratom — a plant-derived supplement that many users say offers relief from depression and anxiety, as well as a natural way to wean off opioids — has “opioid properties,” and recommended that the DEA classify it as a Schedule I drug. In a statement last February, FDA Commissioner Scott Gottlieb […]

US FDA grants Breakthrough Therapy Designation for food allergy drug Xolair

US FDA grants Breakthrough Therapy Designation for food allergy drug Xolair

Xolair (omalizumab), a therapy for the prevention of severe food allergy reactions after accidental exposure, was granted a Breakthrough Therapy Designation​ by the US Food and Drug Administration (FDA). The drug is part of Genentech’s portfolio, which now has twenty-three medicines with Breakthrough Therapy Designation. Currently, there are no preventative treatments for severe food allergies. […]

The FDA Declares War on Yet Another Drug: Reason Roundup

The FDA Declares War on Yet Another Drug: Reason Roundup

David Becker/ZUMA Press/NewscomKratom death reports are rubbish, say advocates. The U.S. Food and Drug Administration (FDA) claims 44 deaths over a 9-year period have been associated with kratom, a Southeast Asian tree whose leaves have mild psychotropic effects when chewed or consumed as tea. A new white paper from molecular biologist Jane Babin suggests the […]

FDA recalls 2 thyroid medications

FDA recalls 2 thyroid medications

WASHINGTON — The Food and Drug Administration has issued a voluntary recall for two thyroid medications made by a Chinese manufacturer because of potential problems with an ingredient. In the Thursday statement, the FDA said Levothyroxine and Liothyronine 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg thyroid tablets are being recalled as a […]

Chagas Disease Drug Now Available with FDA Approval

Chagas Disease Drug Now Available with FDA Approval

A new report from researchers at the Centers for Disease Control and Prevention (CDC) details the investigational use of a drug to treat Chagas disease now available commercially in the United States. Chagas disease is a parasitic infection caused by Trypanosoma cruzi parasites. While mainly found in rural parts of Latin America, movements of individuals […]

FDA Recalls Are Reminder China Controls Much of World's Drug Supply

FDA Recalls Are Reminder China Controls Much of World's Drug Supply

The Food and Drug Administration has broadened a recall of the common blood pressure drug valsartan, saying some batches around the world have been contaminated with a potentially cancer-causing chemical, and the warning has served as a reminder of a drug market that’s increasingly outsourced to other countries.  While no product sold in the U.S. has […]

Valsartan Recall: FDA Adds More Firms in Recall of Blood Pressure Drug

Valsartan Recall: FDA Adds More Firms in Recall of Blood Pressure Drug

More companies were added to a U.S. Food and Drug Administration recall of blood pressure and heart medicine containing a possible carcinogen, according to an update on Aug. 8. Valsartan, according to the FDA, is used as a component in drugs that is to treat high blood pressure as well as congestive heart failure. The […]

'It never goes away': Bettendorf woman hopes new FDA-approved drug curbs migraine attacks

'It never goes away': Bettendorf woman hopes new FDA-approved drug curbs migraine attacks

If Cherri Jackson’s head doesn’t feel like it was hit with a baseball bat, it’s a good day. The Bettendorf woman suffers from chronic migraines, a disabling illness that affects about 3.2 million Americans, or 2 percent of the population, according to the International Headache Society. Despite using a combination of eight treatments, including a […]

FDA recalls two thyroid medications

FDA recalls two thyroid medications

The FDA is recalling two thyroid medications because of potential problems with an ingredient. The medication is Levothyroxine and Liothyronine in doses of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg. The FDA says the Chinese maker of one of the ingredients in the drugs was found to have deficient manufacturing practices in […]

FDA Approves Oral Drug for Fabry Disease

FDA Approves Oral Drug for Fabry Disease

The US Food and Drug Administration has approved the sale of the oral drug migalastat (Galafold), manufactured by Amicus Therapeutics, for treatment of Fabry disease. The average price will be $315,000 per year for each patient, Reuters reports today (August 13). Fabry disease is a rare genetic condition in which a type of fat called […]

1 2 3 89