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FDA pulls approval for only drug meant to reduce preterm birth

Por: The Hill Health April 08, 2023

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The Food and Drug Administration (FDA) is pulling its approval of the only drug on the market for reducing the risk of preterm birth in pregnant women, citing a lack of effectiveness demonstrated by the treatment. The FDA approved Makena in 2011 under its accelerated approval pathway as a treatment for reducing the risk of preterm birth in women pregnant with one child and who have a history of spontaneous preterm birth. the product after a key... + full article



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