FDA approves a Medtronic PMA for the Inceptiv closed-loop rechargeable spinal cord stimulator for treating chronic pain.
CBER director Peter Marks outlines the top priorities at the Center this year that include updating the Centers tissue guidance to reduce the risk of ...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Laboratory Values.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Performance Status.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Med...
Elekta Instrument recalls its Disposable Biopsy Needles from one batch (837838839) because they possibly contain some microscopic stainless steel debr...
FDA approves Pfizers Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for treating adults with moderate to severe hemophilia B.
InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlu...
