U.S. Food and Drug Administration staff questioned the effectiveness of Adeza Biomedical Corp.'s Gestiva drug because new findings were at odds with an earlier government-funded trial, according to documents released on Monday.(link)
Data for the drug, which aims to prevent pre-term births, also showed a possible increase in miscarriages and stillbirths in women who used it, the agency staff said ahead of an FDA advisory panel scheduled to discuss the drug on Tuesday.
Monday, August 28, 2006
Pre-term birth drug
Here's one to watch: