Reuters reports that the Department of Justice has opened a criminal investigation into Cassava Sciences over allegations it manipulated results in a ...
FDA approves Bavarian Nordics fill and finish facility in Denmark to manufacture its Jynneos smallpox/monkeypox vaccine.
FDA publishes a guidance with recommendations on including patients who have not received available therapy in non-curative settings.
FDA clears a Viz.ai 510(k) for its Viz Subdural (SDH), an algorithm that uses artificial intelligences to automatically detect subdural hemorrhages.
FDA approves an additional indication for GlaxoSmithKlines Benlysta to treat children with active lupus nephritis who are receiving standard therapy.
FDA warns Shrewsbury, NJ-based Bi-Coastal Pharma International about CGMP violations in its manufacturing of finished drugs.
FDA warns St. Louis, MO-based Jost Chemical Co. about CGMP deviations in its production of active pharmaceutical ingredients.
FDA places a clinical hold on an unidentified Immuron investigational drug being evaluated for treating campylobacter and enterotoxigenic escherichia ...
