Lilly asks FDA for an EUA for a monoclonal antibody used in Covid-19 monotherapy.
FDA chief counsel Stacy Cline Amin tells FDLI that the Covid-19 emergency has offered the agency an opportunity to set a new legal precedent that will...
FDA issues a draft guidance recommending the inclusion of premenopausal women in breast cancer drug clinical trials.
FDA warns Battelle that the medical device reporting procedure and processes it has in place under an EUA for its respirator decontamination system ar...
CBER director Peter Marks says that if vaccine manufacturers are not sufficiently transparent, FDA has procedures such as a commissioners finding to p...
FDAs win in getting the White House to back down on its threats to block a controversial Covid-19 guidance illustrates a victory for science and a los...
The University of Kentucky asks FDA to recall two lots of acetazolamide after its tests show reduced levels of the active ingredient and increased imp...
FDA denies a Public Citizen petition on Amags Makena while starting the process to have the drug withdrawn because its confirmatory trial did not demo...