Pediatric Cancers

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Investigators previously assessed treatment with opaganib in patients with advanced cholangiocarcinoma and prostate cancer.
Opaganib Earns FDA Orphan Drug Status in Neuroblastoma

August 27th 2024

Investigators previously assessed treatment with opaganib in patients with advanced cholangiocarcinoma and prostate cancer.

Results from the phase 2 AGAVE-201 trial of axatilimab for patients with relapsed/refractory chronic GVHD support the FDA approval.
FDA OKs Axatilimab in Pediatric/Adult Chronic GVHD

August 14th 2024

Phase 1 data may support the potential activity and safety of VCN-01 among pediatric patients with refractory retinoblastoma.
VCN-01 Earns Rare FDA Pediatric Drug Status in Retinoblastoma

August 1st 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.
FDA Accepts Resubmitted BLA for Remestemcel-L in Pediatric SR-aGVHD

July 24th 2024

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

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