The Food and Drug Administration on Wednesday approved a cancer drug from Pharmacyclics and Janssen Biotech Inc. for a new use against a rare blood and bone marrow disease. The agency said it approved Imbruvica for patients with chronic lymphocytic leukemia who have already tried at least one other therapy.
A majority of federal health experts said Tuesday that new research is not strong enough to...
Federal health experts are taking a second look this week at the heart safety of pain...
Some of the world's biggest drugmakers are playing...
Just as heart attack symptoms may differ between men and women, so do stroke risks. Now, the American Heart Association has issued its first guidelines for preventing strokes in women. They focus on birth control, pregnancy, depression and other risk factors that women face uniquely or more frequently than men do.
The U.S. Homeland Security Dept. is warning airlines flying to Russia that terrorists may try to smuggle explosives on board hidden in toothpaste tubes. The threat was passed onto airlines that have direct flights to Russia, including some that originate in the U.S., according to a law enforcement official speaking Wednesday on condition of anonymity because he was not authorized to discuss details of the warning.
The Food and Drug Administration said Friday it is reviewing the safety of popular testosterone drugs for men in light of recent studies suggesting they can increase the risk of heart attack, stroke and death. A study suggested testosterone therapy could double the risk of those problems in men older than 65. Another study published in November found that the hormone increased the risk by 30%.
Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the U.S. Food and Drug Administration (FDA). But a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.
A panel of federal experts has recommended approval for an experimental blood thinner from Merck despite serious side effects including internal bleeding. The Food and Drug Administration's panel of cardiology experts voted 10-1 Wednesday in favor of approving the pill vorapaxar to help prevent blood clots in patients with a history of heart attacks.
New research finds that the social benefits of autonomous vehicles will outweigh the likely disadvantages. Decreased crashes, increased mobility, and increases in fuel economy will drive the technology forward, says RAND Corp. researchers, despite privacy concerns and need for updates in insurance regulations.
The U.S. Department of Agriculture opened the door Friday to commercial sales of corn and soybean seeds genetically engineered to resist the weed killer 2,4-D, which is best known as an ingredient in the Vietnam War-era herbicide Agent Orange. The U.S. military stopped using Agent Orange in 1971, and it has not been produced since the 1970s.
Biogen Idec said Monday the U.S. Food and Drug Administration (FDA) extended its review of Alprolix, a drug designed to treat hemophilia B. Biogen Idec said the FDA extended its review by three months. The move came after the agency asked Biogen for more information about validation of part of the Alprolix manufacturing process.
Bruker Corp. has announced that it has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens. The clearance marks progress in Bruker’s efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.
The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits. In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges."
Within the pharmaceutical industry, the rapid identification, elucidation and characterization of synthetic, process impurities and degradation products is an intense and comprehensive undertaking. In the development of a formulated drug substance, the U.S. Food and Drug Administration (FDA) requires that all impurities introduced in the proposed process above 0.1% must be isolated and fully characterized.
Activists taking part in U.N. climate talks say Japan's decision to drastically scale back its target for reducing greenhouse gas emissions will hurt the battle against global warming. The new target approved by the Japanese Cabinet calls for reducing emissions by 3.8% from their 2005 level by 2020.
The U.S. Food and Drug Administration has approved a new drug from Pharmacyclics and Janssen Biotech Inc. to treat a rare and aggressive form of blood cancer. The agency says it approved Imbruvica for patients with mantle cell lymphoma who have already received at least one previous drug therapy.
The widespread use of advanced surveillance technologies by state and local police departments will improve the efficiency of criminal investigations. But a lack of oversight and regulation poses significant privacy concerns, warns Stephen Rushin, a professor of law at the Univ. of Illinois.
Slapping a 20% tax on soda in Britain could cut the number of obese adults by about 180,000, according to a new study. Though the number works out to a modest drop of 1.3% in obesity, scientists say that reduction would still be worthwhile in the U.K., which has a population of about 63 million and is the fattest country in Western Europe. About one in four Britons is obese.
New research from North Carolina State Univ. and the Univ. of Minnesota finds that people in the U.S. want labels on food products that use nanotechnology—whether the nanotechnology is in the food or is used in food packaging. The research also shows that many people are willing to pay more for the labeling.
The U.S. Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely abused prescription painkiller. The agency said it approved the extended-release pill Zohydro ER for patients with pain that requires "daily, around-the-clock, long-term treatment" that cannot be treated with other drugs.
The U.S. Food and Drug Administration has issued a positive review for a highly anticipated hepatitis C drug from Gilead Sciences, saying the pill cures more patients in less time than currently available treatments. The agency posted its review of Gilead's sofosbuvir online ahead of a meeting Friday where government experts will vote on whether to recommend the drug's approval.
Federal health advisers dealt a major blow to specialty drugmaker Amarin Corp., saying that the government should delay expanding approval of the company's prescription fish-oil drug until more patient data is available. The U.S. Food and Drug Administration's panel of outside advisers voted 9-2 against recommending broader use of Vascepa, a form of fish oil designed to lower triglycerides, a type of fat in the bloodstream.
Bayer HealthCare said Tuesday its drug Adempas has been approved as a treatment for two types of pulmonary hypertension, or high blood pressure in the arteries of the lungs. Bayer said it is already launching the drug, and called Adempas the first drug approved by the Food and Drug Administration as a treatment for more than one type of the disease.
A biotech drug from Roche has become the first medicine approved to treat breast cancer before surgery, offering an earlier approach against one of the deadliest forms of the disease. The U.S. Food and Drug Administration (FDA) approved Perjeta for women with a form of early-stage breast cancer who face a high risk of having their cancer spread to other parts of the body.
Linking global warming to public health, disease and extreme weather, the Obama administration pressed ahead Friday with tough requirements to limit carbon pollution from new power plants, despite protests from industry and Republicans that it would dim coal's future. The proposal, which would set the first national limits on heat-trapping pollution from future power plants, is intended to help reshape where Americans get electricity.
Government cancer experts say a drug from Roche has shown effectiveness as a new option to treat breast cancer before tumor-removing surgery. The U.S. Food and Drug Administration panel voted 13-0, with one abstention, that the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks.
The U.S. Environmental Protection Agency (EPA) has launched a web-based tool, called ChemView, to significantly improve access to chemical specific regulatory information developed by EPA and data submitted under the Toxic Substances Control Act. The tool displays key health and safety data in an online format that allows comparison of chemicals by use and by health or environmental effects.
Federal regulators have approved Celgene Inc.'s drug Abraxane to treat late-stage pancreatic cancer. In experimental trials, the drug extended the lives of patients by a little less than two months more than those treated with the current standard drug.
- Page 1