FDA grants Janssen Pharmaceutical an accelerated approval for Balversa (erdafitinib), a treatment for certain adult patients with locally advanced or ...
FDA says it is helping to mitigate a temporary shortage of pediatric breathing tubes due to the recent closure of Sterigenicss Willowbrook, IL sterili...
Federal Register notice: FDA determines the regulatory review period for Shionogis Symproic (naldemedine tosylate) for treating opioid-induced constip...
Federal Register notice: Based on a de novo request, FDA classifies Timpels Enlight 1810 ventilatory electrical impedance tomograph into Class 2.
Bipartisan legislation is introduced in the House to permanently repeal the medical device excise tax.
FDA clears an Elucent Medical 510(k) for the EnVisio Surgical Navigation System to identify the location of the tissue to be removed.
Takara Bio files a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade.
FDA clears an Ortho Clinical Diagnostics 510(k) for the Vitros XT MicroSlides, featuring new multi-test technology that allows labs to run two tests s...