Lates News

Sanofi announced on September 22 that the U.S. Food and Drug Administration (FDA) has extended the review date of the new drug application (NDA) for the BTK inhibitor Tolebrutinib by three months. Based on supplementary analysis data submitted during the review period, the FDA deemed the additional information to constitute a significant revision to the NDA, and therefore extended the target action date accordingly. The revised FDA decision target date is now December 28, 2025. Sanofi expressed confidence in the potential positive therapeutic effects of this product.