Cell Sorter Fails to Win Approval
ROCKVILLE, Md--The FDA has denied a request by CellPro, Inc. (Bothell, Wash) to approve its cell sorting device Ceprate SC, used investigationally to purify bone marrow or peripheral blood autografts by concentrating CD34+ stem cells. The FDA has asked the company to provide additional information on the device.
ROCKVILLE, Md--The FDA has denied a request by CellPro, Inc. (Bothell,Wash) to approve its cell sorting device Ceprate SC, used investigationallyto purify bone marrow or peripheral blood autografts by concentratingCD34+ stem cells. The FDA has asked the company to provide additionalinformation on the device.
FDA Approves Encorafenib/Cetuximab Plus mFOLFOX6 for Advanced BRAF V600E+ CRC
December 20th 2024The FDA has granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
