FDA Approves First Oral PCSK9 Inhibitor, Merck's Lipfendra

Merck's Lipfendra, the first pill-based PCSK9 inhibitor, won FDA approval on July 16, 2026. PCSK9 inhibitors block a protein that raises LDL ("bad") cholesterol; until now they required injection. In trials, the once-daily pill cut LDL up to 59% alongside statins. Merck priced it above $300 monthly. Wider use may follow, given the convenience of oral delivery.