FDA approves changes to Baraclude labeling to report data from a post-marketing safety study.
FDA grants EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies.
Federal Register notice: FDA seeks comments on a draft document that details best practices for drug safety surveillance.
Michigan Sen. Gary Peters say he intends to investigate solutions to increasing drug prices and drug shortages.
CDRHer Stacy Cho outlines elements in a draft guidance to create an Accreditation Scheme for Community Assessment pilot program.
FDA approves a Sanofi supplemental BLA for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older.
The Alliance for a Stronger FDA advocates for increased FDA funding in fiscal year 2020 because growing responsibilities require a budget that grows....
FDA says the Zimmer Biomet recall of ROSA 3.0 robotic surgery systems is Class 1.