FDA Calls for Restrictions on Ovarian Cancer Drug Rubraca Due to High Mortality Rates
If the drug maker Clovis does not update the Rubraca label, the FDA may seek third party recommendations on whether to remove Rubraca from the market
If the drug maker Clovis does not update the Rubraca label, the FDA may seek third party recommendations on whether to remove Rubraca from the market
Many drugs and medical procedures used on children have never been tested on children in clinical trials for safety and informed consent reasons.
Manufacturers often use data from adults to determine the safety and efficiency of pediatric heart devices, researchers found.
The risk of death from Ukoniq side effects results in the drug being removed from the market less than two years after receiving FDA approval.
Similar problems, including an increased risk of death, have plagued other drugs from the same class in the past, the FDA warns.
Amid a growing number of Enfamil and Similac lawsuits, alleging the manufacturers failed to disclose the baby formula NEC risk, a new study highlights the overall lack of scientific rigor in infant formula clinical trials.