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FDA Roundup: May 31, 2024

FDA Roundup: May 31, 2024
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United statesEli lillyHealth data in medical device developmentAutonomous medical systems saams collaborative communityOffice of media affairsDrug administrationModerna modernatx incPilot programOpenoximetry collaborative communityJuno therapeutics incDigital medicine societyComputer interface collaborative communityCenters for medicare medicaid servicesCenters for diseaseRespiratory syncytial virus vaccineSafeguarding therapeutics act

Jazz Pharmaceuticals Showcases Pioneering Research in Sleep Medicine at SLEEP 2024

Jazz Pharmaceuticals Showcases Pioneering Research in Sleep Medicine at SLEEP 2024
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United statesKelvin tanAndrean flynnKristin bhavnaniA survey of patientsNational health serviceJazz pharmaceuticalsAnalysis of the national healthInternational classification of sleep disordersDrug administrationNational academies pressUnited states drug enforcement agencyDrug enforcement agencyJazz pharmaceuticals incOffice of orphan product developmentAmerican academy of sleep medicine

U S Food and Drug Administration Approves Bristol Myers Squibb s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma

U S Food and Drug Administration Approves Bristol Myers Squibb s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma
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United statesUnited kingdomBristol myers squibbJohn cunninghamBryan campbellHemophagocytic lymphohistiocytosisMichael wangMeghan gutierrezLymphoma research foundationEuropean unionExchange commissionUniversity of texas md anderson cancer centerDepartment of lymphomaDrug administrationDivision of cancer medicineImportant safety information

FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS

FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS
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Sarah yimOffice of therapeutic biologicsDrug administrationAmgen incAlexion pharmaceuticalsTherapeutic biologicsDrug evaluationBoxed warningRisk evaluationMitigation strategy

FDA Approves Bkemv, an Interchangeable Biosimilar to Soliris

The approval was supported by data from the double-blind, active-controlled, 2-period crossover, phase 3 DAHLIA study.

Drug administrationBoxed warningRisk evaluationMitigation strategy