The Senate Health, Education, Labor & Pensions Committee votes 21-2 to advance S. 934, the FDA Reauthorization Act of 2017, that would reauthorize FDA...
FDA clears a NxStage Medical 510(k) for its next generation hemodialysis system, NxStage System One.
FDA clears an NDS 510(k) for its new ZeroWire Mobile battery-powered display stand solution, which is intended to enable untethered clinical mobility ...
FDA grants accelerated approval for Mercks Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and carboplatin, for first-line treatment ...
FDA warns Indiana University School of Medicines Merrill Benson about objectionable conditions at a clinical trial of an investigation drug for which ...
FDA releases an FDA-483 with seven observations from an agency inspection at Indias Aurobindo Pharma.
Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbrev...
Federal Register notice: FDA withdraws approval of a new animal drug application at the sponsors request because the product is no longer manufactured...