FDA approves fast track designation for an acute myeloid leukemia indication for Celularitys CYNK-001 cell therapy.
FDA approves Novartis Cosentyx to treat two forms of arthritis in some pediatric and adult patients.
FDA grants fast track designation for BioArctic and Eisais early Alzheimers drug lecanemab.
FDA approves Novartis Leqvio to lower cholesterol in specified high-risk adults.
Federal Register notice: FDA seeks comments on whether it should grant an exclusive patent license to Houston, TX-based Voxel Systems for the governme...
FDA issues a guidance on 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use.
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on cert...
FDA approves Lillys Rezvoglar insulin glargine biosimilar.