FDA Revokes Approval of Only Preterm Birth Drug.

The FDA has revoked the approval of Makena, the only drug cleared to reduce the risk of preterm birth, due to a lack of evidence that it works. The decision marks the end of a long-running saga involving the drug, which was approved in 2011. Preterm birth is a serious condition that disproportionately affects Black women and women of color, and about 1 in 10 babies in the US are born prematurely. The cause of preterm birth is unknown, and there are currently no effective treatments for the condition.