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FDA Approves Lerodalcibep, Third-Generation PCSK9 Inhibitor to Treat Hypercholesterolemia, Including HeFH / image credit ©waldenmarus/stock.adobe.com
FDA Approves Lerodalcibep, Third-Generation PCSK9 Inhibitor, to Treat Hypercholesterolemia, Including HeFH

December 18th 2025

Phase 3 LIBerate data showed sustained LDL-C reductions of 60% or more in high-risk patients and 50% or more in HeFH, with once-monthly self-administration.

Oral PCSK9 Inhibitor Enlicitide Meets All End Points in Phase 3 Hypercholesterolemia Trial
Oral PCSK9 Inhibitor Enlicitide Meets All End Points in Phase 3 Hypercholesterolemia Trial

September 2nd 2025

FDA Expands Evolocumab Indication to Adults at Risk for Major Cardiovascular Events Due to Uncontrolled LDL-C
FDA Expands Evolocumab Indication to Adults at Risk for Major Cardiovascular Events Due to Uncontrolled LDL-C

August 26th 2025

RDX-002 Hits Primary and Secondary Endpoints for Post-GLP-1 Weight Management / image credit ©missbobbit/stock.adobe.com
RDX-002 Hits Primary and Secondary End Points for Post–GLP-1 Weight Management

August 14th 2025

FDA Label Update Positions Inclisiran as First-Line Monotherapy for Hypercholesterolemia /image credit ©muhammed/stock.adobe.com
FDA Label Update Positions Inclisiran as First-Line Monotherapy for Hypercholesterolemia

August 1st 2025

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