FDA clears a Waypoint Orthopedics 510(k) for the Waypoint GPS, a smart bone awl for use during pedicle screw pilot hole drilling.
FDA releases a final guidance entitled Reporting and Mitigating Animal Drug Shortages that covers voluntary submissions from sponsors so agency can he...
FDA grants Globus Medical a humanitarian device exemption to allow the marketing of the Reflect Scoliosis Correction System.
Federal Register notice: FDA publishes its final decision rendered last month to withdraw approval of Covis Pharma Groups Makena (hydroxyprogesterone ...
Federal Register notice: FDA makes available a final guidance entitled Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Qu...
Federal Register notice: FDA determines that 18 drug products listed in the notice were not withdrawn from sale due to safety or effectiveness concern...
FDA grants Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer.
Rated Class 1 by FDA, Cordis recalls its Angioguard RX/XP Emboli Capture Guidewire System due to device separation concerns.
