Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
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.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect