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Makena

Showing 3 posts of 3 posts found.

FDA committee votes to pull US approval for AMAG’s preterm birth drug Makena

October 31, 2019
Sales and Marketing FDA, Makena, pharma

An FDA committee has passed a contentious vote recommending by a slim majority for the withdrawal of existing approval of …

News

AMAG Pharmaceuticals’ shares fall 21% after failed Makena trial

March 11, 2019
Sales and Marketing AMAG Pharmaceuticals, Makena, PROLONG, birth, trials

AMAG Pharmaceuticals’ Makena (hydroxyprogesterone caproate) has failed to meet its co-primary endpoints in a trial of patients with a history …

News
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FDA-approved preterm birth drug has no benefit and may cause harm, study suggests

March 15, 2017
Research and Development FDA, Makena

A study by the UT Southwestern Medical Center has found that the synthetic progestogen hormone 17-alpha hydroxyprogesterone caproate (17-OHPC), a …

News

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