Health

Sanofi Faces FDA Rejection Over Teplizumab Review

Updated 2026-05-07 14:05 UTC 1 source Negative

Sanofi withdrew its application for teplizumab from a fast-track review program after disagreement with the FDA over its approval. The decision comes amid political appointee pressure, raising questions about regulatory processes.

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STAT News
Sanofi asked the FDA to pull teplizumab out of a speedy review voucher program after a political appointee disagreed with staff over its approval
2026-05-07 13:47 UTC
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