The Justice Department says a Virginia man who pleaded guilty to distributing misbranded drugs via the Internet has been sentenced to two years in fed...
Foundation Medicine petitions FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline variant detection t...
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.
