Wednesday, August 30, 2006
Adeza drug doesn't need new trial: FDA experts
FDA advisors recommend no new tests for Gestiva in prevention of preterm births.
NEW YORK -- A U.S. advisory panel on Tuesday said Adeza Biomedical Corp. did not need to conduct another study to show its drug Gestiva was effective in helping prevent premature births in women who previously delivered a baby too early.
The Food and Drug Administration panel of outside experts made the recommendation in a 12-9 vote against another trial for Adeza's (up $0.61 to $15.91, Charts) experimental drug.
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