FDA Approvals - FDA Approves Orphan Drug Status For Revolutionary Cancer Drug For
FDA Approves Orphan Drug Status For Revolutionary Cancer Drug For Children (Medical News Today)
The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation's unique drug product for children with Ewing's Sarcoma cancer.
FDA Approvaes Powerlink XL System For The Treatment Of Abdominal Aortic Aneurysms In Patients With Large Aortic Necks (Medical News Today)
Endologix, Inc. (Nasdaq:ELGX) today announced U.S. Food and Drug Administration (FDA) approval of the PMA supplement for its Powerlink XL System, which includes new suprarenal stent grafts as well as the new Powerlink XL stent graft.
AMAG Pharmaceuticals Receives Complete Response Letter From FDA For Ferumoxytol (Medical News Today)
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for ferumoxytol for the treatment of iron deficiency anemia in chronic kidney disease patients. The Company submitted its New Drug Application for marketing approval of ferumoxytol in December 2007.