First NME Approved through Commissioners National Priority Voucher (CNPV) Program
Today, FDA approved Lilly’s GLP-1 oral tablet as the first approval of a new molecular entity (NME) through the CNPV program. The FDA says the drug Foundayo (orforglipron), “was approved 50 days after the NDA was filed and 294 days before the application’s PDUFA date of January 20, 2027”. According to the FDA (here), commissioner […]
