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).
In arguing for its market withdrawal, an FDA briefing document says Covis Makena is not effective and has known risks.
Fresenius Kabi recalls its Ivenix Infusion Systems large volume pump software due to a software design issue.
Yale University researchers say FDA should consider three ways to enhance the timely and robust assessment of drug safety signals from FAERS.
