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Eli Lilly’s path to what looked like a surefire blockbuster got derailed by an unforeseen FDA rejection, clouding the future of a drug the company viewed as a pipeline in a pill.

The Food and Drug Administration declined to approve Lilly’s baricitinib, an oral treatment for rheumatoid arthritis. According to Lilly, the agency wants to see more clinical data to determine the safety and ideal doses for the drug. Lilly didn’t disclose whether that means it will have to recruit and run new studies of the treatment, but if so, a resubmission could be delayed by months.

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