FDA releases the form FDA-483 with 12 observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug and biologic product ...
Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologic applications.
FDA clears a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing Helicobacter pylori.
FDA says it does not expect any immediate impact on drug supplies due to tornado damage at Pfizers Rocky Mount, NC sterile drug manufacturing.
FDA posts an International Council for Harmonization-developed guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities ...
The Biden Administration threatens to veto a House spending measure that includes cuts to FDAs budget.
Syndax Pharmaceuticals and Incyte plan to file by the end of the year a BLA for axatilimab, for use in adult and pediatric patients with chronic graft...
Horizon Therapeutics says a Phase 2 clinical trial evaluating daxdilimab for treating systemic lupus erythematosus failed to meet its primary endpoint...
