Eiger BioPharmaceuticals, Inc.’s peginterferon lambda, Gilead Sciences, Inc.’s magrolimab, Takeda Pharmaceutical Co. Ltd.’s TAK-994 and Bavarian Nordic A/S’s RSV vaccine are the latest entrants to the small group of products that received breakthrough therapy designations but went on to struggle with clinical failure, changing strategic priorities, and regulatory missteps.
Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short
Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.
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