FDA approval

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.

FDA approves pembrolizumab for a subset of ovarian cancer patients after Phase 3 KEYNOTE-B96 trial shows the first overall survival benefit ever demonstrated by an immunotherapy in this setting.