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FDA Finally Pulls Preterm Birth Drug Makena From the Market

FDA withdrawal of Makena from the market comes four years after the drug, granted accelerated approval in 2011, failed a post-marketing study to confirm the drug’s benefit. The FDA decision also affects generic versions of the drug.

Robert califfCovis pharmaLuxembourg based covis pharmaScientist namandjCommissioner robertWeight lossMedical devicesHealthcare innovationMedcity newsMedcity newsSan franciscoLife sciencesRock healthStartup adviceStartup fundingPatient monitoring system

FDA: Ignore the false racial equity argument for keeping Makena

A pharma company is arguing that Makena should be kept on the market because it may work in Black people. But it doesn't work in any people.

Martha nolanCovis pharmaHuman developmentDrug administrationBristol myers squibbUs national institute of child healthLuxembourg based covis pharmaApollo globalChild healthAdeza biomedicalNew england journalOptimizing neonatal gestation

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