FDA denies without comment on potential future action a Taiho petition seeking restrictions on generic versions of its Lonsurf tablets.
FDA says it is ordering labeling changes to benzodiazepines to highlight risks of abuse, misuse, addiction, withdrawal symptoms, etc.
FDA grants priority review for Pfizers Xalkori sNDA to treat some pediatric lymphoma patients.
FDA commissioner Stephen Hahn testifies on Capitol Hill to reassure lawmakers and the public that a transparent science- and data-based review, and no...
Federal Register notice: FDA determines that Carmel Biosciences Prexxartan (valsartan) oral solution was not withdrawn due to safety or effectiveness ...
FDA commissioner Stephen Hahn and CDC director Robert Redfield dismiss notions that a deep state operates within their agencies intent on damaging pre...
FDA warns Coupler Enterprises about CGMP violations in its manufacturing of finished drugs.
FDA says it will update regulations to clarify the types of evidence it considers when determining the intended use of a medical product.