1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher pilot program. 

Issued 50 days after filing — and 294 days before the application’s PDUFA date of 20 January 2027 — this decision represents a historic milestone as the first new molecular entity (NME) approved under the program.  It is also the fastest approval of an NME since 2002.

Read FDA press release