Merck's Lipfendra wins FDA approval as the first oral PCSK9 inhibitor for adults with high LDL cholesterol after positive Phase 3 results.

The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former commissioner Marty Makary.

Merck and the FDA announced the approval of enlicitide 20 mg as an add-on to diet and exercise to lower LDL in adults with hypercholesterolemia and those with heterozygous…

With enlicitide, large LDL cholesterol reductions possible without a needle