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Nexletol partners Esperion and Daiichi Sankyo patch up milestone dispute with $125M settlement

Nexletol partners Esperion and Daiichi Sankyo patch up milestone dispute with $125M settlement
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Oliver appelhansDaiichi sankyoSheldon koenigEuropean medicines agencyEsperion therapeutics

Esperion settles lawsuit with European distribut Daiichi Sankyo

Esperion settles lawsuit with European distribut Daiichi Sankyo
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New yorkUnited statesDaiicho sankyo europeDaiicho sankyoSheldon koenigRoger newtonPfizer incUs district courtEuropean economic area

FDA approves expanded indications for bempedoic acid and combination tablet

FDA approves expanded indications for bempedoic acid and combination tablet
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Sheldon koenigErik swain

FDA Approves Updated Label for Bempedoic Acid, Ezetimibe Tablets

The update also removed the maximally tolerated qualifier for statin use and the statement that said morbidity and mortality was not yet determined.

Sheldon koenigEsperion therapeutics

U S FDA Updates LDL-C Lowering Indication for Esperion s NEXLETOL® (bempedoic acid) Tablet and | Region

– Updated Label Adds Primary Hyperlipidemia, Removes Maximally Tolerated Statin Requirement, Removes Limitation of Use –

Sheldon koenigTiffany aldrichAlexis callahanEsperion therapeutics incExchange commissionDrug administrationUpdated label adds primary hyperlipidemiaRemoves maximally tolerated statin requirementRemoves limitationRisk reduction labels remainAnticipated approvalSupplemental new drug applicationsCholesterol loweringInhibiting regimenEsperion therapeuticsAdverse event