Covidien won CE mark approval in Europe for its new acute care ventilation system.
Jubilant Life Sciences says the FDA has given it a clean bill of health on a facility in Montreal, Canada, that was issued a warning letter in February 2013. The drugmaker has another facility in Spokane, WA, where the FDA still has concerns.
Amarin, which has faced a series of setbacks getting its fish oil pill to market, is lashing out at the FDA for some of its problems, Bloomberg reports.
The FDA has granted its fast-track status to Actelion's Phase III drug for C. difficile-related diarrhea, promising a shorter path to approval for the antibiotic treatment.
The FDA has reduced the number of new drug shortages considerably, and hospitals have gotten much better at responding when they occur. But the total number of drug shortages continues to grow, and patients continue to suffer as a result.
The Galaxy S5 is soon to be the first smartphone on the market with a built-in heart rate monitor. The monitor is designed for fitness use, but according to South Korea's health agency, it may subject the highly anticipated new phone to med tech-level regulation before its maker, Samsung, can sell the phone in its own home country.
It's Johnson & Johnson's last stand in Arkansas. The drugmaker has its chance Thursday to persuade the Arkansas Supreme Court to toss out the $1.2 billion judgment awarded in a court fight over Risperdal marketing.
With its potential for addiction and its lack of abuse-deterrent features, Zogenix's Zohydro painkiller had its critics even before its regulatory green light in October. Now, with the powerful product on the market, a coalition of activists is taking its protest to the next level.
Merck's Januvia, Novo Nordisk's Victoza and their brethren are in the clear. After a new round of safety reviews, U.S. and European regulators found little evidence that widely used diabetes drugs known as incretin mimetics cause pancreatitis or pancreatic cancer.
All of the Big Three devicemakers have worked to get their pacemakers certified compatible with MRI scans, but it doesn't look like they'll need to undertake similar efforts to ensure their patients will be safe in a CT scan.