FDA rejects Repligen’s imaging agent, shares drop
(Reuters) – Repligen Corp said U. S. health regulators denied approval for its imaging agent to detect structural abnormalities in the pancreas, sending its shares down 10 percent. The U. S. Food and Drug Administration has asked for additional efficacy and safety trial data to approve the agent, called RG1068, in a complete response letter. Repligen said in April that it did not expect the FDA to approve the imaging agent as the regulator had canceled an advisory committee meeting to review the agent. . . .
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