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.
Former Pharmakon Pharmaceuticals CEO Paul J. Elmer and compliance director Caprice R. Bearden are convicted of conspiracy to defraud FDA and nine coun...
A new FDA update says the findings from duodenoscope studies now show that up to 5.4% of all properly collected samples tested positive for high conce...
FDA grants Janssen Pharmaceutical an accelerated approval for Balversa (erdafitinib), a treatment for certain adult patients with locally advanced or ...