Sarepta Therapeutics says regulators at the Food and Drug Administration have told it they were open to reviewing its next experimental treatment for Duchenne muscular dystrophy, meaning that it could file an application for the new medicine by the end of this year.
Tobacco companies could be forced to slash the amount of nicotine in US cigarettes, under radical plans from the Food and Drug Administration
In a bid to drastically reduce the number of U.S. deaths attributed to smoking each year, the Food and Drug Administration on Thursday unveiled a tobacco regulation plan that is notable for its breadth and simplicity: strip cigarettes of their power over users by reducing their nicotine content...
The approval by the Food and Drug Administration of 23andMe’s BRCA test is bound to create a discussion about the merits and pitfalls of direct to consumer genetic testing for cancer risk. It is also going to add fuel to a growing fire...Show More Summary
The Food and Drug Administration recently made public warning letters sent to several companies in the U.S. and other countries about violations of federal food safety rules. Companies are allowed 15 working days to respond to FDA warning letters. Show More Summary
The Food and Drug Administration has been getting at least $1 billion annually in recent years, including salaries for at least 4,300 full-time professionals, for food safety and nutrition. Since the enactment of the Food Safety Modernization Act (FSMA) in January 2011, FDA has published 33 proposed or final key recommendations, and 111 draft or... Continue Reading
WASHINGTON (Reuters) - U.S. Food and Drug Administration chief, Scott Gottlieb, criticized pharmacy benefit managers, health insurers and drugmakers on Wednesday for "Kabuki drug-pricing constructs" that profit the industry at the expense of consumers.
(Reuters) - The U.S. Food and Drug Administration is investigating new reports of Bayer's implanted birth control device Essure causing problems during removal, the agency said on Wednesday, two years after it slapped a warning label on the product.
(WASHINGTON) — U.S. regulators have approved the first direct-to-consumer breast cancer gene test. But the Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe. The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene…
The Food and Drug Administration (FDA) issued a new warning about the risk of heart disease for people who take clarithromycin.
The Endocrine Society today expressed disappointment with the U.S. Food and Drug Administration's (FDA) statement asserting that the results of an interim report support previous determinations that bisphenol A (BPA) is safe for use in food containers and packaging.
(Reuters) - KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain, sending the shares of the drugmaker up as much as 36 percent in late afternoon trading.
On February 14th, the U.S. Food and Drug Administration (FDA) approved a blood test that has been proposed to diagnose concussion. Many media outlets quickly reported this announcement as being a breakthrough in concussion diagnosis...
(Reuters) - KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain.
(Reuters) - The U.S. Food and Drug Administration on Wednesday said it recalled and destroyed a large volume of kratom-containing dietary supplements made by a company in Missouri.
Four years ago, the U.S. Food and Drug Administration released a draft risk profile on the public health dangers associated with spices, identifying the presence of pathogens such as Salmonella and filth in general. It described efforts...Show More Summary
The Food and Drug Administration alerted pet owners Friday about potential pentobarbital contamination in several brands of dog foods manufactured by The J.M. Smucker Co. The warning came after a media outlet reported the results of a study that found low levels of pentobarbital in some samples of Gravy Train canned dog food. The drug... Continue Reading
(Reuters) - The U.S. Food and Drug Administration on Friday granted approval for expanded use of AstraZeneca Plc's, immunotherapy drug, Imfinzi, to treat non-small cell lung cancer whose tumors can't be surgically removed.
(Reuters) - The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences Inc's Vitaros, a cream to treat erectile dysfunction, for the second time in a decade, sending the company's shares down more than 70 percent before the opening bell.
The U.S. Food and Drug Administration has approved a new dose of Sandoz’s multiple sclerosis therapy Glatopa (glatiramer acetate injection) that is twice as large as the currently authorized one. Regulators’ approval of the 40 mg/mL applies to people with relapsing forms of MS. Show More Summary