FDA Approvals - DOR BioPharma Receives Not Approvable Letter From FDA for orBec(R)
DOR BioPharma Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-vs.-Host ... (Marketwire via Yahoo! Finance)
DOR BioPharma, Inc. announced today that it has received a not approvable letter from the US Food and Drug Administration for its lead product orBec for the treatment of acute gastrointestinal Graft-versus-Host disease, a common and potentially life-threatening complication of hematopoietic cell transplantation.
APP Receives Two FDA Approvals For Fludarabine Phosphate (Medical News Today)
Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), announced two approvals from U.S. Food and Drug Administration (FDA) to market the liquid and lyophilized versions of Fludarabine phosphate. [click link for full article]