A controversial treatment for preventing premature births will be reviewed by a Food and Drug Administration advisory panel on Tuesday amid intensifying debate over whether the medication, called Makena, should remain on the market.
The panel is set to review a required followup study that found the medicine was not effective, a troublesome development given that Makena has become the standard of care since winning FDA approval nine years ago. The results have called into question the extent to which physicians should continue to use the treatment and prompted intense betting on Wall Street about what the FDA will do.
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