FDA clears Sanofi's teplizumab for children with stage 3 type 1 diabetes

The FDA approved Sanofi’s teplizumab, sold as Tzield, for children aged 8 and older with stage 3 type 1 diabetes , STAT News reported, broadening access to a drug previously cleared for delaying the onset of the disease in higher-risk patients.

The approval matters for pediatric patients, who make up a large share of new type 1 diagnoses, but the timing is its own story: STAT notes the decision landed after the agency’s expedited review deadline. A missed target date on a priority review is a small but real signal worth watching for what it says about FDA throughput and staffing.

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