The FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages. But that was not the case with a regulatory update Monday on argenx’s autoimmune disease star Vyvgart.
Food and Drug Administration databases that physicians and public health experts rely on for key drug safety and manufacturing information have been neglected due to DOGE-directed layoffs, leaving health professionals flying blind on basic questions about certain drugs they're prescribing, current and former FDA officials tell Axios.
If a grocery store steeply discounted rotting cuts of meat or produce, would you buy them? Probably not. By the same logic, if a pharmacy tried to sell medications that are understrength or contaminated, few of us would go along. Bad meat you can smell or taste, but you can’t do that for bad meds. Unfortunately, we can’t be sure that our generic drugs are consistently safe and effective, because they aren’t independently tested before they’re sold. We simply assume they are safe.
Apellis’ recently approved eye injection Syfovre (pegcetacoplan injection) has been linked to several cases of retinal vasculitis, a rare complication involving eye inflammation, according to the American Society of Retina Specialists’ Research and Safety in Therapeutics Committee, as reported by several media outlets.
Intercept’s woes have continued as a possible new liver toxicity signal was buried in a regulatory filing. What could this mean?
With more sophisticated testing, the pharma industry is turning up more impurities and new risks in drugs approved long ago. The FDA figures that trend will only continue. The question then becomes, how does the industry to move forward?
Concerns over the safety of the U.S. drug supply were recharged as Glenmark Pharmaceuticals initiated the recall all of nearly 2,000 lots of its Zantac generics from the U.S. market because they may contain elevated levels of a possible cancer-causing impurity.
Federal health officials on Wednesday rolled out two new draft guidances about how to study drug safety and efficacy in pregnant and lactating women, the latest in a series of steps to make sure women have the information they need to make medical decisions.
For decades, pharmaceutical companies have used animal testing and clinical trials to determine the effectiveness and safety of new drug formulas.
But these methods have proved to be costly, dangerous and highly inefficient. To fix this, global biotech firm Novoheart has developed the world’s first miniature beating human hearts using stem cells.