Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Detention and Banned Medical Devices.
FDA sends HutchMed a complete response letter on its NDA for surufatinib, indicated for treating pancreatic and extra-pancreatic neuroendocrine tumors...
FDA denies a Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minneapolis, MN, who repea...
Federal Register notice: FDA issues Regeneron Pharmaceuticals a priority review voucher under its material threat medical countermeasure product progr...
FDA clears an Auris Health (Ethicon subsidiary) 510(k) for its Monarch surgery platforms expansion to endourological procedures.
Federal Register notice: FDA withdraws the accelerated approval of Acrotech Biopharmas NDA for Marqibo (vincristine sulfate liposome injection), indic...
FDA issues a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combination with gemcitab...
FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide.