Overview
- The initial vouchers went to therapies spanning vaping cessation (Cytisinicline), congenital deafness (DB-OTO), pancreatic cancer (RMC-6236), infertility/IVF (Pergoveris), ketamine, Augmentin, Type 1 diabetes (Teplizumab), erythropoietic protoporphyria (Bitopertin) and vision loss (Cenegermin).
- FDA leaders said reviews will be accelerated by convening a multifunctional team to cut idle time, though selections do not guarantee approval and some decisions may still take longer than two months.
- Officials cited domestic manufacturing goals in choosing ketamine for general anesthesia and the antibiotic Augmentin.
- Each FDA division nominated one product under criteria aligned with national priorities, including unmet public health needs and lowering costs.
- Commissioner Martin Makary said the nine awards constitute the first of two batches, with additional selections expected in the coming weeks.