FDAs Anesthetic and Analgesic Drug Products Advisory Committee issues a split vote (6 to 6) on the approval of Durect Corp.s surgical pain drug Posimi...
Federal Register notice: FDA requests nominations for members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committee.
A new FDA safety communication recommends that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer ...
Medtronic issues an urgent field safety notice about the potential for navigational inaccuracy when its O-arm O2 Imaging Systems auto-registration fea...
Fusion IV Pharmaceuticals (dba Axia Pharmaceutical) recalls all unused sterile drug products within expiry due to a lack of sterility assurance.
Bipartisan House Energy and Commerce Committee ask FDA to provide information on the agencys approval performance on complex generic drugs, saying the...
TG Therapeutics begins a rolling NDA submission for umbralisib, a dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously t...
Federal Register notice: FDA submits to OMB an information collection extension for BLA general licensing provisions.