FDA Ad Com thumbs down on full Makena approval

FDA Ad Com thumbs down on full Makena approval

Source: 
Seeking Alpha
snippet: 

The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 16-0 that AMAG Pharmaceuticals' (AMAG) confirmatory study, Trial 003, failed to demonstrate Makena's effectiveness in reducing the risk of preterm births in women with histories of singleton spontaneous preterm birth.