FDA clears a Syntr Health Technologies 510(k) for the SyntrFuge System and its use in surgical specialties when the transfer of harvested adipose tiss...
A Florida federal judge sentences two people to jail time and restitution for participating in a conspiracy to falsify clinical trial data.
CDRH says it met or exceeded strategic goals in the period 2018-2020.
FDA approves Mercks Keytruda plus Eisais Lenvima for first-line treatment of adults with advanced renal cell cancer.
FDA grants Allogenes ALLO-715 orphan drug status for treating multiple myeloma.
FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating idiopathic hypersomn...
FDA places a clinical hold on Bluebird Bios Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected serious adverse reacti...
Federal Register notice: FDA solicits comments on several issues related to FDAs post-approval regulation of certain drug products approved in abbrevi...