FDA warns Results RNA about CGMP violations in its production of finished drugs.
FDA praises a DC federal court decision backing the way the agency determines clinical need for bulk drug substances to be compounded by outsourcing f...
FDA releases its latest batch of Warning Letters that includes Premium Production and Results RNA.
FDA says it is confidence that AveXis Zolgensma should remain on the market despite manufacturer reports of a data manipulation problem with some of t...
Three stakeholders suggest changes to an FDA draft guidance on clinical trial diversity enhancement.
FDA approves Bracco Diagnostics Aribar Thin Liquid (barium sulfate) for oral suspension, indicated for modified barium swallow studies.
Abbott recalls its Ellipse Implantable Cardioverter Defibrillators after electrical failures had been identified.
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2020.