FDA approves a GSK BLA for Priorix (measles, mumps and rubella vaccine) for use in individuals 12 months of age and older.
Bristol Myers Squibb withdraws a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion dependent beta t...
Federal Register notice: FDA withdraws its guidance entitled Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applicati...
An appeals court rules that it does not have jurisdiction to hear disputes arising from FDA complete response letters because they are not final agenc...
The Washington State Supreme Court rules that doctors, and not drug companies, bear responsibility to warn patients about potential adverse events whe...
FDA classifies as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventila...
FDA says Novavaxs Covid-19 vaccines two-dose primary series demonstrated significant efficacy results in clinical trials, but it also showed similar r...
FDA releases a final guidance entitled Electromagnetic Compatibility (EMC)of Medical Devices that offers the agencys current thinking on recommended i...