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First Three Novel Biologic Suffixes Came Courtesy Of US FDA, Not Sponsors

Executive Summary

FDA assigned a four-letter nonproprietary name suffix to Genentech's Hemlibra because an expedited review left little time to evaluate the sponsor's late-submitted proposals; UltraGenyx asked FDA to assign one for Mepsevii, while Spark submitted 10 suffix candidates for Luxturna only to see all of them rejected for being too meaningful.

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