FDA approves Boston Scientifics Watchman FLX left atrial appendage closure device.
FDA issues a guidance with its current thinking on the regulatory criteria for human cells, tissue, and cellular and tissue-based product minimal mani...
FDA clears a Paige 510(k) for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis.
FDA releases its latest batch of Warning Letters that includes Centurion Medical Products, Signa SA de CV facility and Stason Pharmaceuticals.
AstraZeneca reports positive interim data from an the ongoing Phase 1-2 COV001 trial, which showed that its AZD1222 vaccine was tolerated and generate...
Federal Register notice: FDA withdraws a notice of opportunity for a hearing that proposed to withdraw the approved uses of carbadox, a carcinogenic a...
Federal Register notice: FDA proposes an order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used i...
FDA extends by six months its enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products due to the Covid-19...