FDA clears an Iterative Scopes 510(k) for SKOUT, a computer-aided polyp detection device for adults undergoing colorectal cancer screening.
Senate Health, Education, Labor and Pensions Committee leaders reach agreement to reauthorize FDAs user fee programs for an additional five years, wit...
FDA grants regular approval to Eli Lilly for its previously accelerated-approval Retevmo (selpercatinib) for treating certain adult patients with loca...
Staff in the FDA Oncology Center of Excellence say ways must be found to improve studies leading to accelerated approval to shorten the time in which ...
FDAs Oncologic Drugs Advisory Committee votes 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals Pozenveo (poziotinib) and its...
Former U.S. Attorney Gregory Brower discusses four takeaways from a recent Department of Justice memo on increased corporate enforcement actions.
FDA posts a draft guidance entitled How to Obtain a Covered Product Authorization for generic drug developers having trouble getting samples for devel...
Federal Register notice: FDA determines that GlaxoSmithKlines prescription-only NIX (permethrin) 1% topical creme rinse was not withdrawn from sale fo...
