GAITHERSBURG, Md. - The FDA's Anti-Infective Drugs Advisory Committee voted against expanding the label for Factive (gemifloxacin) to include acute bacterial sinusitis, absent an additional study to demonstrate its superiority. (BioWorld Today)

SILVER SPRING, Md. - The FDA's Oncology Drugs Advisory Committee on Thursday disagreed with a shortened approval pathway for Abraxane (paclitaxel) as an adjuvant breast cancer treatment, which would expand its label. (BioWorld Today)

SILVER SPRING, Md. - The FDA's Oncology Drugs Advisory Committee on Thursday disagreed with a shortened approval pathway for Abraxane (paclitaxel) as an adjuvant breast cancer treatment, which would expand its label. (BioWorld Today)

SILVER SPRING, Md. - The FDA's Oncology Drugs Advisory Committee on Wednesday rejected Genta Inc.'s new drug application for Genasense (oblimersen sodium) to treat relapsed or refractory chronic lymphocytic leukemia, driving down the company's stock value for a second consecutive day. (BioWorld Today)

SILVER SPRING, Md. - The FDA's Oncology Drugs Advisory Committee on Wednesday rejected Genta Inc.'s new drug application for Genasense (oblimersen sodium) to treat relapsed or refractory chronic lymphocytic leukemia, driving down the company's stock value for a second consecutive day. (BioWorld Today)