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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 States Hemophagocytic Lymphohistiocytosis Satu Glawe Peter Lebowitz Obrian Kenney Data Monitoring Committee

Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel)

The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival compared to standard regimens CARTITUDE-4 is the... | June 6, 2023
United States New Jersey Ying Huang Hemophagocytic Lymphohistiocytosis European Hematology Association Janssen Biotech Inc

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 States Satu Glawe Binod Dhakal Hemophagocytic Lymphohistiocytosis Legend Biotech United States Inc National Cancer Institute

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Trodelvy® Continues to Show Durable Overall Survival Advantage in Pre-Treated HR+/HER2- Metastatic Breast Cancer

– Trodelvy – the First Trop-2-Directed ADC – Delivers a Durable and Clinically Meaningful 3.3 Month Improvement in Median Overall Survival vs. Comparator Chemotherapy in Phase 3... | June 5, 2023
United States Foster City Sara Tolaney Gilead Sciences College Of American Pathologists Gilead Sciences Inc

Ciltacabtagene Autoleucel (cilta-cel) Reduced Risk of Disease Progression or Death by 74% vs Standard Regimens for Adult Patients with Relapsed and Refractory Multiple Myeloma in CARTITUDE-4 Study

First analysis data from CARTITUDE-4 demonstrated a statistically significant improvement in progression-free survival, with a hazard ratio of 0.26 CARTITUDE-4 is the first randomized study... | June 5, 2023
New Jersey United States Hemophagocytic Lymphohistiocytosis European Hematology Association Janssen Biotech Inc Medicinal Devices Agency

Ciltacabtagene Autoleucel (cilta-cel) Reduced Risk of Disease Progression or Death by 74% vs Standard Regimens for Adult Patients with Relapsed and Refractory Multiple Myeloma in CARTITUDE-4 Study

05.06.2023 - Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that results from the Phase 3 CARTITUDE-4 ...
United States New Jersey Mythili Koneru Hemophagocytic Lymphohistiocytosis Binod Dhakal Exchange Commission On

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