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.
FDA approves an emergency use authorization for a Roche rapid at-home Covid-19 test.
FDA gives an emergency use authorization to a Siemens at-home 15-minute Covid antigen test.
FDA grants an additional orphan drug designation to Senhwa Biosciences silmitasertib, this time to treat patients with medulloblastoma.
FDA warns Maumee, OH,-based Spartan Chemical Company about CGMP violations in its production of misbranded unapproved new drugs.