A couple of geriatrics experts have joined the chorus of recommendations against testosterone therapy. But they're going a step further. They say drugmakers' enthusiastic advertising--which happened to be effective, too--was actually disease-mongering.
The FDA says it won't recommend new limits on Eli Lilly schizophrenia med Zyprexa Relprevv after almost a year of investigating the deaths of two patients 3 to 4 days after they received injections.
Johnson & Johnson won a split decision in Philadelphia court Friday, in the latest Risperdal lawsuit to go to trial. A jury decided that J&J did fail to warn doctors that the antipsychotic drug could cause breast development in boys, Reuters reports.
Gilead Sciences' superselling hepatitis C drugs have hit a speed bump after 9 patients taking either Harvoni or Sovaldi, as well as a common drug for heart arrhythmias, had serious reactions. One of the 9 had a heart attack and died. Three others had to receive pacemakers.
The FDA is rushing to complete guidance on abuse-deterrent opioids before the end of June because if it doesn't, Congress has promised to take away $20 million in money for salaries and expenses in the FDA Commissioner's Office and give it instead to its criminal investigations unit to fight drug diversion.
Celiac sufferer Michael Weber is suing the FDA for dragging its feet on a citizen petition he filed in 2008. The lawsuit attempts to force the FDA to either ban gluten from use in drugs or at least require labels to indicate it is an ingredient in prescription and over-the-counter drugs.
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."