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.
The FDA accepted Tzield's supplemental biologics license application (sBLA) for expedited review under the Commissioner's National Priority Voucher pilot program due to 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 drug is included in the agency’s program based on its potential to address a large unmet medical need.
Author's summary: Tzield gains expedited FDA review.
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