Pediatric Cancers

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Upon acceptance, the FDA will review the resubmitted application between 2 and 6 months for remestemcel-L in pediatric patients.
BLA Resubmitted for Remestemcel-L in Pediatric Steroid-Refractory GVHD

July 10th 2024

Upon acceptance, the FDA will review the resubmitted application between 2 and 6 months for remestemcel-L in pediatric patients.

The FDA approval of the single-agent, oral pan-RAF inhibitor tovorafenib is based on efficacy results from the phase 2 FIREFLY-1 trial.
FDA Approves Tovorafenib for Relapsed/Refractory Low-Grade Glioma

April 23rd 2024

Findings from an open-label trial support the FDA approval of inotuzumab ozogamicin as a treatment for pediatric patients with relapsed/refractory acute lymphoblastic leukemia.
FDA Approves Inotuzumab Ozogamicin in Pediatric CD22+ ALL

March 6th 2024

Administering pegylated asparaginase continuously to pediatric patients with acute lymphoblastic leukemia appears to be safe without compromising the efficacy of treatment.
Continuous PEGasparaginase Prevents Antibody Formation in Pediatric ALL

February 12th 2024

FDA initiatives such as the Food and Drug Omnibus Reform Act will set goals and specify measures for improving representation in pediatric cancer clinical studies.
Hispanic Population Appears Underrepresented in Pediatric Cancer Trials

January 31st 2024

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