Aveo Oncology says its Phase 3 trial of Fotivda plus BMS Opdivo in some renal cell cancer patients did not meet the progression-free survival primary ...
FDA clears a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option.
FDA grants Restore Medical a breakthrough device designation for its ContraBand device and its use in treating certain heart failures with reduced eje...
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-erosive gastroesophagea...
FDA says two additional Warning Letters have been issued to Chinese medical device firms as part of its evaluation of defective plastic enteral syring...
FDA releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing facility.
FDA publishes a guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies of invest...
Federal Register notice: FDA makes available a final guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.
