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Janssen Submits Supplemental Biologics License Application to U S FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma

/PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA).

United statesHemophagocytic lymphohistiocytosisSatu glawePeter lebowitzObrian kenneyData monitoring committeeEuropean commissionLegend biotech united states incEuropean hematology associationJanssen pharmaceutical companiesNone of janssen research developmentExchange commissionDrug administrationAmerican society of clinical oncologyJanssen research developmentJanssen biotech inc

Janssen Submits Supplemental Biologics License Application to U S FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Janssen Submits Supplemental Biologics License Application to U S FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma
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United statesSatu glaweHemophagocytic lymphohistiocytosisObrian kenneyPeter lebowitzJanssen research developmentJanssen biotech incCompanies of johnsonJanssen pharmaceutical companies of johnsonEuropean commissionLegend biotech united states incEuropean hematology associationJanssen pharmaceutical companiesData monitoring committeeAmerican society of clinical oncologyNone of janssen research development

CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study

/PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that results from the Phase 3 CARTITUDE-4 study showed CARVYKTI®.

United statesSatu glaweBinod dhakalHemophagocytic lymphohistiocytosisLegend biotech united states incNational cancer instituteEuropean commissionCongress abstractNone of janssen research developmentExchange commissionAmerican cancer societyDivision of hematologyJanssen biotech incEuropean medicines agencyEuropean hematology associationJanssen pharmaceutical companies of johnson

Johnson & Johnson : CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study

News Release Media Contacts: Jessica Castles Smith +1 732-501-8181 Satu Glawe +49 172-294-6264 . | June 5, 2023

United statesSatu glaweBinod dhakalDivision of hematologyClinical development cellular therapy programEuropean medicines agencyJanssen biotech incCongress abstractEuropean commissionCollege of wisconsinLegend biotech united states incJanssen pharmaceutical companies of johnsonAmerican society of clinical oncologyJanssen research developmentDrug administrationNews release

CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) Reduces

At 16 months median follow-up, cilta-cel significantly improved progression-free survival compared to two standard of care treatment regimens1 .

United statesRegion flamandeCiltacabtagene autoleucelEdmond chanAmerican society of clinical oncology annual meetingEuropean medicines agencyAmerican cancer societyCongress abstractJanssen biotech incJanssen research developmentJanssen pharmaceutical companiesAmerican society of clinical oncologyEuropean hematology associationEuropean commission grants conditional approvalLegend biotech united states incNone of the janssen pharmaceutical companies