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OncLive s May Roundup of Key FDA Approvals in Oncology

OncLive s May Roundup of Key FDA Approvals in Oncology
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United statesLuis pazAnjee davisLeoi gordonSaurabh dahiyaLuniversidad complutenseMatt sauseWorld health organizationStanford university school of medicineJohn friend professor of oncology researchCel wins accelerated approvalRefractory follicularStanford university schoolCell therapySnags accelerated approvalHospital doce de octubre

Roche granted FDA Breakthrough Device Designation

Roche announces that the Tina-quant lipoprotein Lp(a) RxDx assay receives Breakthrough Device Designation from the FDA

Matt sauseEuropean atherosclerosis societyCanadian cardiovascular societyHeart societyEuropean society of cardiologyNational lipid associationDrug administrationProduct newsBreakthrough device designationEuropean societyBeijing heart society

Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

Approximately one in five people worldwide have elevated Lp levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics.

United statesNathalie altermattJay bradnerSabine borngrKarsten kleineRebekka schnellSimon goldsboroughLoren kalmBirgit masjostKirti pandeyYvette petillonSileia urechBruno eschliColl cardiolMatt sauseRoche group

F Hoffmann-La Roche Ltd: Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) - a key marker for hereditary cardiovascular risk

Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics Tina-quant®

United statesMatt sauseSabine borngrKarsten kleineRebekka schnellSimon goldsboroughBirgit masjostYvette petillonJay bradnerNathalie altermattSileia urechLoren kalmKirti pandeyBruno eschliEuropean society of cardiologyCanadian cardiovascular society

FDA Grants Breakthrough Device Designation to Blood Test Measuring Lp(a)

FDA Grants Breakthrough Device Designation to Blood Test Measuring Lp(a)
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Clin lipidolJay bradnerColl cardiolMatt sauseDrug administrationNational lipid associationBreakthrough device designationLipid associationScientific statementClinical practiceDevice designationCardiovascular risk thresholds