FDA approves an Amgen supplemental NDA to add positive overall survival data from the Phase 3 ASPIRE trial to the prescribing information for Kyprolis...
FDA clears a Centinel Spine 510(k) to market its FLX Platform of integrated interbody and non-integrated interbody fusion devices.
FDA approves a Cellenkos IND to proceed with a Phase 1 clinical trial of CK0801, third-party cord blood-derived regulatory T cells, in patients with b...
FDA Review posts the Federal Register notices for the week ending 6/8/2018.
FDA approves an AbbVies Venclexta (venetoclax tablets) in combination with rituximab for treating patients with chronic lymphocytic leukemia or small ...
FDA clears an Edap TMS 510(k) for its Focal One device for ablating prostate tissue.
Federal Register notice: FDA corrects a 5/15 proposed rule to amend its regulations concerning the classification of products as biological products, ...
Federal Register notice: FDA announces a 6/27 public workshop entitled Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic F...