The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, on July 16, 2026.

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

Merck’s pill, called Lipfendra, is a PCSK9 inhibitor, which works in a different way than a statin to lower cholesterol.

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

The U.S. FDA has approved Merck's new cholesterol-lowering pill, Lipfendra. This oral medication works by blocking the PCSK9 protein, which helps lower bad cholesterol. Lipfendra…

The FDA has cleared Merck’s Lipfendra for patients whose artery‑clogging cholesterol remains high despite statins.

The Food and Drug Administration on Thursday approved Merck's Lipfendra, which some have hailed as a breakthrough in cholesterol management.

The Food and Drug Administration (FDA) approved on Thursday a first-of-its-kind oral option that can lower "bad" LDL cholesterol with a daily pill instead of a shot.

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, on July 16, 2026.

Merck’s once-daily Lipfendra offers a pill alternative to injectable cholesterol drugs after Phase 3 trials involving Israeli patients

The FDA has approved Merck's once-daily cholesterol pill Lipfendra (enlicitide), marking the first oral PCSK9 inhibitor.