FDA commissioner Scott Gottlieb continues to use his bully pulpit to rail against the pharmaceutical industry and its increasing drug costs for Americ...
Federal Register notice: FDA makes available a final guidance entitled Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.
FDA issues a complete response letter for Sandoz BLA for a biosimilar version of Genentechs cancer drug Rituxan.
FDA and Alnylam Pharmaceuticals agree on a trial size and primary endpoint for a Phase 3 trial of lumasiran to treat primary hyperoxaluria type 1.
FDA issues a guidance explaining how it is implementing PDUFA 6 user fee changes.
The DC District Court rules in FDAs favor to dismiss a suit by the Center for Responsible Science that sought new warnings on informed consent documen...
FDA releases the FDA-483 with four observations issued following an inspection at the QuVa Pharma drug outsourcing facility in Temple, TX.
FDA tells members of two advisory committees that InfaCares stannsoporfin appears to be effective in treating hyperbilirubinemia but may be associated...