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Morning! Hope you had a delightful weekend. Up today: an exclusive look at the scientific mix-up behind the approval of preterm birth drug Makena. We hear from a mother of a son with Duchenne muscular dystrophy who wants to ensure the FDA’s accelerated approval pathway stays strong, and more.
The mix-up behind a controversial drug for preterm birth
Last year, the FDA withdrew its approval of Makena, the progesterone-based drug meant to prevent preterm birth, when follow-on studies failed to prove its efficacy. A little-known facet to the Makena story is largely untold, as STAT’s Annalisa Merelli writes, describing a key error in the widely cited study that underpinned the drug’s initial approval.