Medicare is the biggest buyer of lab-based diagnostic tests in the U.S., and the program overpaid by about $910 million in 2011, according to a federal report, lining the pockets of companies like Quest Diagnostics and LabCorp.
St. Jude Medical scored FDA approvals for the latest in its banner lines of implanted defibrillators, saying the new generation is less likely to scrape against leads and put patients at risk.
The FDA has sent Baxter International a warning letter laying out problems it found during inspections at a plant in North Carolina as well as at a plant in Jayuya, Puerto Rico.
Abbott Laboratories has met success at every turn with Absorb, the company's dissolvable stent, and now it's kicking off a trial to get the device on the market in Japan.
Sagent Pharmaceuticals, which relies primarily on contract manufacturers, is recalling a paralyzing agent used in surgery that is manufactured at a plant in Turkey. The company said testing found a high level of impurities.
Trying to limit access to Teva Pharmaceutical Industries' emergency contraceptive Plan B One-Step and other similar birth control drugs has been a long battle, but the government has finally decided to cut its losses. As of Monday, it will no longer be fighting for age-based restrictions on over-the-counter availability.
Exact Sciences has completed its three-step process to win FDA approval for a stool-based cancer diagnostic, submitting the same data that spooked investors back in April with hopes of convincing the agency.
The FDA announced that regulators are providing a priority review for the treatment, potentially lopping four months off of the review process.
The long-awaited battle between two weight loss drugs is ready to begin. With its launch for Belviq delayed by the DEA, Arena has had to sit back and watch competitor Vivus pass it by with its own weight-loss drug. Now, nearly a year after the FDA cleared Belviq for approval, investors will get the chance to see if it can outperform its underwhelming competitor, Qsymia.
It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory panel recommended the FDA keep Avandia on the market and ease restrictions on its use.