FDA and university researchers publish a BioCompute Object Specification document.
Public Citizen asks FDA to require a Boxed Warning and revised REMS warning of the risk of spinal fractures if patients stop taking Amgens Prolia for ...
FDA warns Malaysias Luen Fook Medicine about CGMP violations in its production of an unapproved new drug.
FDA warns RIJ Pharmaceutical about CGMP violations in its production of finished drugs.
FDA stops sales and distribution of surgical mesh products made by Boston Scientific and Coloplast indicated for transvaginal repair of pelvic organ p...
FDA grants CRISPR Therapeutics and Vertex Pharmaceuticals a fast track designation for CTX001 for treating transfusion-dependent beta thalassemia.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry on Registering with the Center for Ve...
FDA allows Mesoblast to submit on a rolling basis a BLA for its allogeneic cellular medicine remestemcel-L for use in children with steroid-refractory...