Browsing: drug approval

The announcement last week took just about everyone by surprise. Scott Gottlieb, MD, the FDA’s well-respected commissioner, would be stepping…

While many drugs are being approved more rapidly, are they much of an improvement over existing medications? What are the…

FDA Decided That Mylotarg, a Leukemia Drug, Should be Made Available Again An FDA advisory committee has decided that the…

The FDA’s March approval of Noctiva (desmopressin) is an example of the agency approving a drug where the risks outweigh…

Nearly one-third of new drugs approved by the FDA over a recent 10-year period were associated with a postmarket safety…

The FDA has approved the first new drug to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease,…

Scott Gottlieb, President Trump’s nominee to head the FDA, is in most ways a conventional (conservative) choice to head the…

Drug companies, politicians and patient groups are clamoring for faster approval of drugs. But doing so could bring potentially harmful…

Many drugs are approved that aren’t all that effective in the “real world.” Why is the FDA approving drugs that…

The battle over the FDA’s potential approval of eteplirsen, a drug to treat Duchenne muscular dystrophy, demonstrates the power of…