Two stakeholders call for changes to an FDA draft guidance on safety testing of human allogeneic cells expanded for use in cell-based medical products...
House Republican leaders postpone a floor vote this week on FDAs fiscal year 2025 budget.
FDA approves a Mirum Pharmaceuticals label expansion for Livmarli (maralixibat) oral solution for treating cholestatic pruritus in patients with progr...
Abbott begins a medical device correction for some of its FreeStyle Libre 3 sensors due to potential incorrect high glucose readings.
FDA establishes a docket for information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins.
FDA releases the form FDA-483 with three observations from an inspection at Biocon Biosphere in Andhra Pradesh, India.
Pfizer plans to discuss with FDA its path to seek approval of its investigational gene therapy for treating adults with moderately severe to severe he...
Federal Register notice: FDA announces that it revoked a Mesa Biotech emergency use authorization for the Accula SARS-CoV-2 Test.
