Salix Pharmaceuticals nabbed the new Relistor approval it was counting on. The FDA blessed the injectable drug as a treatment for all patients with constipation caused by opioid pain relievers, boosting its target market more than tenfold.
A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.
Nightscout touts itself as an open source, do-it-yourself project to enable remote monitoring of blood glucose levels of patients with Type 1 diabetes.
Gilead has been seeking FDA approval for HIV drugs Tybost and Vitekta for a while now, but the agency dealt the drugmaker a setback with Complete Response Letter last year. Now, 17 months later, the two have passed muster.
Infraredx isn't a big company yet. But the Massachusetts maker of an intravascular imaging system designed to help diagnose and manage coronary artery disease continues to meet major goals for international expansion. The latest: Japan's regulators granted approval for its signature device.
The FDA's powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress' procedural requirements when reclassifying devices, including notice and comment procedures.
The problem of contaminated cold remedies has once again surfaced in the U.S. More than seven years after diethylene glycol put authorities on high alert, a toddler in New York has suffered from lead poisoning after taking a Chinese cold remedy.
Among the scrum of drugmakers racing forward with a new class of cancer treatments, Bristol-Myers Squibb was the first to win a global regulatory nod and is now first in line for approval in lung cancer, a particularly lucrative indication for the group of promising oncology drugs.
It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis and Roche. Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.
Indian CRO GVK Biosciences is working to get back in the good graces of European regulators after inspectors found evidence that its employees doctored clinical trial results.