STAT+: FDA panel votes that a controversial premature birth medication should be withdrawn
After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.
The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.
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