Novo Nordisk

The FDA approved Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist from Eli Lilly, for adults with obesity or overweight. It is the first new molecular entity approved under the National Priority Voucher program and the fastest NME approval since 2002.

Novo Nordisk's Awiqli reduces basal insulin injections from 365 to 52 per year, winning FDA approval after a 2024 rejection over manufacturing and safety concerns.

The FDA cited Novo Nordisk for serious violations of adverse event reporting requirements after a 2025 inspection found the company failed to report three patient deaths linked to semaglutide, including one suicide, and lacked adequate procedures for post-marketing drug safety surveillance.