STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more

RegulatoryteplizumabNegative

AI Analysis

Summary

Sanofi requested the FDA withdraw teplizumab from an expedited review voucher program following disagreement between a political appointee and FDA staff regarding the drug's approval.

Outcome Details

Sanofi requested removal of teplizumab from FDA voucher program after disagreement between political appointee and FDA staff over approval

Importance:5/10

Sentiment:

-0.40

FDAregulatoryvoucher programapproval processpolitical appointee

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Published by STAT News on May 7, 2026 1:47 PM

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