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Orexigen Therapeutics Inc. says U.S. health officials have declined to approve the experimental weight loss pill Contrave and want the company to conduct an additional study.
The Food and Drug Administration request suggests the agency may yet approve the drug, which analysts have viewed as the most promising of three new diet pills recently submitted to the agency. But the FDA has asked for an additional study to address potential heart safety issues. Get the full story »
Women who have breast implants may be at greater risk for a rare but serious cancer, U.S. health regulators warned Wednesday.
The Food and Drug Administration said it is looking at a possible link between silicone and saline breast implants and a type of anaplastic large cell lymphoma, which targets the immune system. The agency said overall it still believes implants are safe. Get the full story »
Abbott Laboratories’ RX Acculink carotid stent appears to work as well as surgery in opening clogged neck arteries in patients who are not at high risk for complications from the surgical procedure, U.S. health regulatory staff concluded.
The device is already approved for patients who need to have their neck arteries opened up, but would face greater risk of side effects if they underwent a procedure to scrape off built-up fatty deposits that can cause strokes. Get the full story »
The Food and Drug Administration unveiled steps aimed at streamlining the approval process used for most medical devices and deferred decisions on the most contentious issues.
The FDA said Wednesday that it would ask the Institute of Medicine for input on seven proposals, including creation of a new class of devices that would require more data to win approval. Get the full story »
U.S. health reviewers are concerned that clinicians may not be able to properly interpret brain scans using Eli Lilly & Co.’s imaging agent for Alzheimer’s and that the tests may be of limited use in assessing the degenerative disease.
The radioactive dye is intended for use with positron emission tomography, or PET, scans that help detect the presence of beta-amyloid plaques linked to Alzheimer’s disease. Get the full story »
Abbott Laboratories this morning said it will hold off seeking U.S. approval of an experimental psoriasis treatment following feedback from federal regulators who have concerns about the drug.
Abbott would not disclose exactly what the concerns of the U.S. Food and Drug Administration are. The agency, however, has in recent years stepped up its scrutiny of the safety and efficacy of drugs and increasingly orders more study in clinical trials, particularly for safety risks to the heart.
The news hit the company’s stock. The price of Abbott’s shares lost 1 percent of their value or 49 cents, dipping to $46.88 in trading on the New York Stock Exchange. Get the full story »
U.S. health regulators are requesting a limit on the amount of acetaminophen in prescription pain medicines to curb the risk of liver damage.
The move announced on Thursday aims to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and calls for them to carry a “black box” warning about potential liver failure. Get the full story »
Truckloads of Four Loko and other alcohol-laced energy drinks are being recycled into ethanol and other products after federal authorities told manufacturers the beverages were dangerous and caused users to become “wide-awake drunk.”
Wholesalers from Virginia, North Carolina, Maryland and other East Coast states started sending cases of the high-alcohol, caffeinated malt beverages to MXI Environmental Services in Virginia after the Food and Drug Administration cracked down on the sale of such beverages in November. Get the full story »
The Food and Drug Administration is launching a website explaining its regulations to companies as part of a broader effort to rebrand itself as a more transparent, accessible agency.
The website, dubbed “FDA Basics for Industry,” features answers to frequently asked questions about the regulation of food, drugs and medical devices. The FDA also pledged to respond to questions from manufacturers within five business days. Get the full story »
Tobacco maker Star Scientific Inc. says it has developed a moist smokeless tobacco with lower levels of cancer-causing chemicals than any other tobacco product on the market.
The small Virginia company, which sells tobacco lozenges that dissolve in the mouth, said Tuesday that it plans to ask the Food and Drug Administration this quarter for approval to sell the new item as safer than any competing product. Get the full story »
The U.S. Food and Drug Administration issued Invacare Corp. a warning letter for failure to fully address reports of fires and entrapment involving beds made by the company.
In a Dec. 15 warning letter, the FDA said Invacare, which makes a variety of medical equipment used in homes and long-term care facilities, didn’t properly handle or investigate reports of fire and patients becoming trapped in beds. The letter was posted to the agency’s Web site Tuesday. Get the full story »
A beekeeper stirs honey at an apiary near Wuhan of Hubei Province, China. (China Photos/Getty Images)
Honey companies and importers are launching a program in January to try to stop the flow of illegally sourced honey from coming into the country.
The True Source Honey Initiative is an effort by a handful of producers and importers looking to certify the origin and purity of the honey sold to U.S. consumers in jars and products such as cereals, snacks and glazes. Get the full story »
The U.S. Food and Drug Administration has dropped Archer Daniels Midland’s canola crushing plant in Windsor, Ontario from its list of plants that are under import restrictions due to salmonella concerns, according to an update on the regulator’s website on Tuesday. Get the full story »
