Several medical devices are being inspected for cybersecurity flaws by the The Department of Homeland Security.» Read More
The decision was widely expected, after a panel of FDA advisers two weeks ago voted 20-1 against approving the drug, Arcoxia.
Eli Lilly announced Wednesday it has received approval from the FDA to market Reconcile, the first selective serotonin reuptake inhibitor (SSRI) class of antidepressants approved by the FDA for treatment of canine separation anxiety in conjunction with behavior modification training.
Mylan Laboratories spacer said U.S. regulators approved its generic version of Sanofi-Aventis' sleeping pill, Ambien, in the 5 mg and 10 mg strengths.
A bird flu vaccine made by Sanofi Aventis is the first to gets federal approval as a stopgap measure against a potential pandemic until more effective vaccines can be developed.
Boston Scientific said on Monday it had resolved deficiencies that U.S. regulators had found at a plant that manufactures heart rhythm devices, sending its shares up nearly 7%.
Merck's new pain reliever drug Arcoxia, which was proposed as a successor to Vioxx, was rejected by a federal health advisory panel. A Food and Drug Administration drug safety expert earlier told the panel that the drug may increase substantially the risk of stroke and heart attack and is no more effective for pain relief than other medicines in the same class.
An analyst sounded a warning note on shares of biotechnology company Dendreon on Monday, which have more than tripled in value since March 30, but the stock continued to rise.
The Food and Drug Administration doesn’t have the staff to inspect all food imported to the U.S., raising basic health concerns and forcing consumers to take producers' word that it’s safe, a food expert said.
Shares of Dendreon shot up after a panel of FDA advisers voted Provenge is both safe and effective in treating advanced prostate cancer.
Shares of Dendreon are up about 250% in pre-market trading after a panel of FDA advisers voted Provenge is both safe and effective in treating advanced prostate cancer.
Shares of pharmaceutical firm Dendreon leaped on Wednesday following a CNBC report about a planned Thursday Food and Drug Administration hearing that could determine the fate of a prostate cancer drug from the company.
The Southern California farm that grew the green onions that were first linked to and then cleared in last year's E. coli outbreak has filed a libel lawsuit against Taco Bell.
The test, called the Xpert EV test, can detect the condition in 2.5 hours compared with other products that can take as long as a week, the FDA said.
U.S. health regulators have approved GlaxoSmithKline's pill Tykerb for patients with advanced breast cancer after other treatments have failed, a company spokeswoman said on Tuesday.
J.P. Garnier, GlaxoSmithKline's chief executive officer, told CNBC's "Squawk Box" Wednesday that he expects to make the company's new drug for advanced breast cancer available to U.S. patients "within a few days."
The U.S. Food and Drug Administration on Friday issued a public health advisory for three widely-used drugs manufactured by Amgen for the treatment of anemia.
Gen-Probe has won U.S. approval to sell its Procleix blood test to detect the West Nile virus, a Food and Drug Administration spokeswoman said Friday.
A judge on Tuesday sentenced former Food and Drug Administration chief Lester Crawford to three years' supervised probation with fines of roughly $90,000 for lying about stocks he owned in companies regulated by his agency.
Federal health advisers recommended Tuesday that the government approve the first bird flu vaccine as a stopgap measure, despite evidence it wouldn't protect most people.
Genentech shares traded lower after data from a clinical trial indicated that a lower dosage of the blockbuster cancer drug Avastin was as effective as the standard dose for lung cancer patients.