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U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS (mavacamten) Label

16.06.2023 - Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to add positive data from the Phase 3 VALOR-HCM study to the U.S. Prescribing Information for ...
Anjalit Owens Bristol Myers Squibb York Heart Association Bristol Myers Squibb Company Exchange Commission Journal Of The American College Cardiology

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Kite's Tecartus® CAR T-cell Therapy Demonstrates 78% Complete Response Rate and 90% Overall Response Rate in Largest Real-World Evidence Analysis for Relapsed/Refractory Mantle Cell Lymphoma

-- In CIBMTR Registry Analysis, Tecartus Also Demonstrates 88% Complete Response Rate and 94% Overall Response Rate in Second-and-Third-Line Treatment -- -- Data Highlighted in Oral Presentation at... | June 6, 2023
United States Foster City Santa Monica Frank Neumann Swetha Kambhampati Exchange Commission

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

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