Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse ...

Amgen’s Repatha receives US FDA approval for adults at increased risk for MACE due to uncontrolled LDL-C: Thousand Oaks, California Tuesday, August 26, 2025, 17:00 Hrs [IST] Amg ...

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL)cholesterol under control with current ...

THOUSAND OAKS, Calif., Amgen today announced the submission of an application to the U.S. Food and Drug Administration (FDA) seeking approval of a single-dosing option for the monthly administration ...

The Food and Drug Administration (FDA) has expanded the approval of Repatha ® (evolocumab) to include use in adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled ...

Within 4 hours of administration, Repatha exerts maximum suppression of PCSK9 levels, with no clinically meaningful drug-drug interactions with high-intensity statin therapy.

In data from the clinical program to date, Repatha has demonstrated consistent, significant and durable reduction in LDL-C levels with favorable effects on other lipid parameters in approximately ...

Repatha, approved by the U.S. Food and Drug Administration on Aug. 27, is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous ...

Repatha is approved in more than 75 countries, including the U.S., Japan, Canada, Australia, China and in all 28 countries that are members of the European Union.

Amgen Inc. AMGN announced that the FDA has approved a new, monthly single-dose administration option for its PCSK9 inhibitor, Repatha. The Repatha Pushtronex system, an on-body infusor with a ...

Biden Administration asks Supreme Court to reject Amgen's Repatha patent appeal By Blake Brittain September 21, 20224:57 PM PDTUpdated September 21, 2022 ...