DOR BioPharma Announces Results of orBec(R) End of Review Conference With the FDA (Marketwire via Yahoo! Finance)
DOR BioPharma, Inc. today reported the results of its recent End of Review Conference with the Food and Drug Administration for the orBec New Drug Application. The purpose of the meeting was to gain further clarification regarding the deficiencies noted in the October 18, 2007 not approvable letter and the data required to gain approval for orBec for the treatment of gastrointestinal ...

FDA panel rejects drug for breast cancer (Los Angeles Times)
Genentech shares plunge. The vote could be a sign of tougher standards at the agency. A Food and Drug Administration panel dealt a sharp blow to biotech giant Genentech Inc. on Wednesday by refusing to recommend approval for the company's high-profile drug Avastin as a treatment for breast cancer.