FDA warns Mississauga, Canada-based Trexo Robotics Holdings about QS issues in its illegal manufacturing and marketing of robotic medical devices.
FDA publishes a draft guidance outlining the standardized format for electronic submission of BLA, NDA, and selected supplements for planning CBER Bio...
Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Marketing.
Federal Register notice: FDA makes available a draft guidance for industry entitled Processes and Practices Applicable to Bioresearch Monitoring Inspe...
A United States Pharmacopeia 2023 drug shortage report highlights four factors contributing to a decade-high level of shortages that last longer than ...
An FDA advisory committee unanimously votes to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provide protection agains...
Amgen announces positive data from its Phase 3 clinical trial (MITIGATE) evaluating the efficacy and safety of Uplizna (inebilizumab-cdon) for treatin...
The Biosimilars Council calls on FDA to eliminate unnecessary clinical efficacy studies as part of streamlining the biosimilar development paradigm.
