Sanofi (SNY) said the FDA has accepted for expedited review the supplemental biologics license application for Tzield to delay the progression of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older recently diagnosed with stage 3 T1D. The sBLA is supported by the results from the PROTECT phase 3 study.
The company noted that FDA nominated Tzield for the Commissioner's National Priority Voucher pilot program based on its potential to address a large unmet medical need. The CNPV program aims to shorten the review process to 1-2 months.
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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.