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FDA panel recommends pulling preterm birth drug from the market

Por: The Boston Globe Nation October 20, 2022

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A Food and Drug Administration advisory committee on Wednesday recommended removing the drug Makena from the market, after years of study showed the fast-tracked drug had failed to prevent preterm birth.Makena has been in use for 11 years, and the panel’s vote was widely viewed as a test of the agency’s “accelerated approval” program, which has expedited nearly 300 promising drugs to the market in 30 years. The program has been... + full article



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