Brainlab recalls its Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that may prevent t...
FDA grants FibroGen an orphan drug designation for the companys anti-cognitive tissue growth factor antibody, pamrevlumab, for treating patients with ...
FDA approves an Intact Vascular PMA for the Tack Endovascular System, a dissection repair device implanted post-angioplasty in patients with periphera...
FDA clears Gelesis Plenity (Gelesis100) as an aid in weight management in adults with a body mass index of 25 to 40 kg/m when used in conjunction with...
FDA Review posts the Federal Register notices for the week ending 4/12/2019.
FDA Review posts product approval summaries for the week ending 4/12/2019.
FDA approves an expanded label for Mercks Keytruda, Mercks anti-PD-1 therapy, as monotherapy for the first-line treatment of certain patients with Sta...
Federal Register notice: FDA classifies suitable medical device accessories into Class I as required by the FDA Reauthorization Act of 2017.