Merck & Co., Inc. and Ridgeback Biotherapeutics LP’s antiviral molnupiravir satisfied the relatively low threshold for US emergency use authorization as a COVID-19 treatment, but it appears considerably more data, and more convincing data, would be needed to meet the higher standard for full drug approval.
In a decision memorandum, US Food and Drug Administration reviewers cited the “unexplained difference in efficacy results from the...
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