Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Cablivi (caplacizumab-yhdp).
FDA approves Allergan Aesthetics Skinvive by Juvderm and its use to improve skin smoothness of the cheeks in adults.
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Federal Register notice: FDA determines that 18 drug products listed in the notice were not withdrawn from sale due to safety or effectiveness concern...
