Federal Register notice: FDA submits to OMB an information collection extension for Public Health Service Guideline on Infectious Disease Issues in Xe...
FDA accepts for priority review a Bayer NDA for darolutamide for treating non-metastatic castration-resistant prostate cancer.
Federal Register notice: FDA sends to OMB an information collection extension for Administrative Detention and Banned Medical Devices 21 CFR 800.55(g...
FDA revamps its Product-Specific Guidances for Generic Drug Development Web page to add new functionality, including text searching for active ingredi...
FDA clears a CoapTech 510(k) for the PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.
Edwards Lifesciences recalls its Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter due to difficulty in balloon de...
FDA clears a Biofourmis 510(k) for its RhythmAnalytics platform, a cloud-based software designed to automatically interpret cardiac arrhythmias.
Federal Register notice: FDA determines the regulatory review period for Cabaret Biotechs Yescarta (axicabtagene ciloleucel), indicated for treating a...