Federal Register notice: FDA announces that two information collection proposals on establishment registration have been approved by the Office of Man...
FDA clears a Roche 510(k) for its cobas e 801 module for use on the cobas 8000 modular analyzer system.
FDA clears a Coapt 510(k) for its Complete Control System, an intuitive device for controlling advanced prosthetic arms.
Sanofi and Regeneron Pharmaceuticals resubmit their BLA for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients ...
Federal Register notice: FDA announces the availability to license an agency invention for Solid-Phase Purification of Synthetic DNA Sequences.
FDA grants accelerated approval to AstraZeneca for Imfinzi (durvalumab) for treating certain patients with locally advanced or metastatic urothelial c...
Federal Register notice: FDA seeks comments on an information collection for Institutional Review Boards (IRBs) 21 CFR 56.115 OMB Control Number 091...