Pfizer has been lobbying the FDA to back off of the black-box warning on its stop-smoking drug Chantix. But patient groups and others have been pushing back--including a panel of FDA advisers, which voted last year to keep the agency's boldest warning on Chantix's official label.
Following in the footsteps of the FDA, the European Medicines Agency (EMA) has launched an effort to combat antibiotics resistance in people by targeting food animals. The agency has issued two new draft guidelines for assessing and approving veterinary antibiotics.
What's going to save Novartis' reputation in Japan? Science, says CEO Joe Jimenez, a week after the government suspended his Japanese unit for failure to report side effects.
The FDA is taking action to ensure that multidose insulin pens do not spread diseases by requiring the injectable devices to display the warning "For single patient use only."
The Obama administration is already working with nursing homes to reduce inappropriate use of antipsychotic meds such as Seroquel, Risperdal and Zyprexa. But federal investigators now say officials need to focus on overuse in dementia patients.
After nearly a year off the shelves, GlaxoSmithKline's diet pill alli--recalled after reports of tampering--is back in most U.S. stores, and it's got some updates that should make any future tampering easier to spot.
Shire is pushing full steam ahead to get the word out on binge eating disorder, the new indication it snagged for blockbuster Vyvanse last month.
The jury has spoken in Johnson & Johnson's Risperdal trial, and the news wasn't good for the U.S.-based drugmaker. The Philadelphia panel decided J&J had failed to properly warn that the antipsychotic drug could trigger breast development in boys and young men, in the first of more than 1,000 similar cases pending.
Citing rampant use of the same needle to inject more than one person, the World Health Organization has--some might say finally--launched a new policy to make unsafe injections less prevalent. Part of this policy involves adopting up-to-date measures in syringe engineering, promoting the use of "smart" needles with precautions against unsafe use.
Currently, there are several generics on the U.S. market of oral antifungal agent ketoconazole. But consumer advocacy organization Public Citizen is trying to change that.