Topic:
Regulatory
Latest Headlines
Latest Headlines
Report: Dx companies gouging Medicare
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 wins FDA nods for low-friction cardiac devices
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.
FDA warning letter cites Baxter for mold at plant, hair in infusion products
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 takes to Japan with much-hyped Absorb
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 recalls paralyzing agent made by MN Pharmaceuticals
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.
Obama administration allowing Teva's Plan B for all ages
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 wraps up FDA submission as investors keep a watchful eye
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.
Gilead gains FDA's inside track for hep C drug sofosbuvir
The FDA announced that regulators are providing a priority review for the treatment, potentially lopping four months off of the review process.
Battle of weight-loss drugs begins as Arena launches Belviq next week
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.
UPDATED: FDA advisers vote for looser reins on GlaxoSmithKline's Avandia
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.
