FDA Accepts Tzield for Expedited Review
Sanofi's Tzield has gained FDA's expedited review, promising rapid access to innovative treatment for type 1 diabetes and addressing significant medical needs.
Sanofi announced FDA's acceptance of Tzield's supplemental biologics license application (sBLA) for expedited review under the Commissioner's National Priority Voucher pilot program.
The drug is included in the agency's program based on its potential to address a large unmet medical need.
The program reduces the review process from 10-12 months to 1-2 months, while maintaining FDA's rigorous safety and efficacy standards.
The program was designed to reduce the review process from its standard 10-12 month review process to 1-2 months, while maintaining FDA's rigorous safety and efficacy standards.
Author’s summary: Tzield gains expedited FDA review.
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