FDA Gives National Priority Vouchers to Nine Sponsors

The FDA gave its first priority vouchers to nine sponsors under the Commissioner’s National Priority Voucher (CNPV) pilot program to address unmet medical needs.

• Selected Pergoveris for infertility, Sanofi’s Teplizumab for Type I Diabetes, Cytisinicline for nicotine vaping addiction, DB-OTO for deafness, Cenegermin-bkbj for blindness, RMC-6236 for pancreatic cancer, Bitopertin for porphyria, Ketamine for domestic manufacturing of a general anesthetic, and Augmentin XR for domestic manufacturing of a common antibiotic
• CNPV program set to accelerates review time line
  • Recipients to receive decisions within 1-2 months
• Anticipates announcing another group of recipients in the coming months
• Revolution Medicines shares jumped 13% ...