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.
FDA clears a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers.
CDER and CBER partner with the Critical Path Institute to plan for a consortium to facilitate clinical development programs for alpha-1 antitrypsin de...
Two FDA officials describe steps the agency is taking to harmonize its oversight of clinical trials with the HHS Common Rule on protecting those who v...
