Pediatric Cancers

Latest News

The agency has set a Prescription Drug User Fee Act date of January 7, 2025, for its decision on approving remestemcel-L in this patient population.
FDA Accepts Resubmitted BLA for Remestemcel-L in Pediatric SR-aGVHD

July 24th 2024

The agency has set a Prescription Drug User Fee Act date of January 7, 2025, for its decision on approving remestemcel-L in this patient population.

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

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

More News