FDA warns East Stroudsburg, PA-based Royal Chemical Company about CGMP violations in its manufacturing of finished drugs.
FDA warns Ottawa, Canada-based Abbott Point of Care about multiple violations in its manufacturing of the i-STAT cTnI test cartridges to measure cardi...
FDA says some elderly and immunocompromised people are now eligible for a second Moderna or Pfizer BioN/Tech Covid vaccine booster as part of a new si...
FDA researchers describe two lessons learned from rare disease clinical trials during the Covid-19 pandemic and their applicability to future trials.
CDER Office of New Drugs Research Program associate director Laura Jaeger describes the regulatory science research the program has funded.
FDA issues Azure Biotech an emergency use authorization for the Azure Fastep Covid-19 Antigen Pen Home Test.
FDA approves an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating acute migraine.
FDA approves a BlackSwan Vascular PMA for its Lava Liquid Embolic System for treating peripheral arterial hemorrhage.
