Cardiac Lesion Found in 2-Month-Old Child

The expanded approval of methotrexate may offer a convenient alternative to pediatric patients who have difficulty swallowing pills.

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.

Phase 1 data may support the potential activity and safety of VCN-01 among pediatric patients with refractory retinoblastoma.

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.