Generic drug approval times for the second quarter of the current fiscal year dropped sharply, according to new FDA figures.
FDA issues a final order renaming and down-classifying needle destruction devices.
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...