FDA releases a draft guidance listing relevant information the agency wants included in complete test reports for non-clinical bench performance testi...
FDA releases the FDA-483 with 11 observations from a Zimmer Biomet inspection.
FDA clears a Neural Analytics 510(k) for its NeuralBot System, a robotic assistance technology which automatically adjusts orientation and position of...
FDA expands the approval of Pfizers Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Clinical Trial Sponsors: Establishment and Ope...
FDA approves a TherapeuticsMD NDA resubmission for Imvexxy (estradiol vaginal inserts) for treating moderate-to-severe dyspareunia.
FDA approves a PMA for HumanOptics CustomFlex artificial iris, the first standalone prosthetic iris approved in the U.S.
FDA places a clinical hold on a CRISPR Therapeutics and Vertex Pharmaceuticals trial of CTX001 for treating sickle cell disease pending the resolution...