FDA accepts for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating certain adults with pancreatic and extra-pan...
CDRH publishes a discussion paper to seek public feedback on the issue of health equity in the context of medical devices.
Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) introduce a bipartisan bill entitled Innovation in Pediatric Drugs Act (S 4905) that would a...
Smiths Medical corrects software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may occur if the device i...
Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new Loper Bright Suprem...
Medtronic recalls (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative responses.
FDA clears a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscopes compatibility with Advanced Sterilization Products S...
Federal Register notice: FDA announces the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two.
