Zeiss Medical Technology gains 510(k) clearance for MTLawton, disposable bipolar forceps made from a copper-base alloy.
FDA clears a Copan Diagnostics 510(k) for its Colibr, a semi-automated pre-analytical processor that is part of the companys WASPLab laboratory automa...
The American College of Obstetricians and Gynecologists and 48 other reproductive health organizations petition FDA to ask Danco Laboratories to submi...
FDA approves GlaxoSimthKline Biologicals Boostrix vaccine to immunize, during the third trimester, unborn children against pertussis.
Federal Register proposed rule: FDA proposes a regulation to implement its new authority to destroy a device valued at $2,500 or less that has been re...
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2023.
FDA issues Abbott Molecular an emergency use authorization for its Alinity m MPXV and its use in detecting the monkeypox virus.
FDA approves an Alnylam Pharmaceuticals supplemental NDA to expand the label for Oxlumo (lumasiran).
