Xospata (gilteritinib, Astellas)
Indications: Adult patients with relapsed or refractor acute myeloid leukemia (AML) with an FLT3 mutation.
Dosage: 120 mg orally once-daily; 40 mg tablets
Contraindications: Hypersensitivity to gilteritinib or any of the excipients. Naphylactic reactions have been observed in clinical trials.
FDA Issues CRL for Heplisav-B in Adults With ESRD on Hemodialyis
May 14th 2024Dynavax plans to meet with the FDA to discuss how the company can provide additional data to support the approval of its 4-dose Heplisav-B regimen and expand protection for adults with end-stage renal disease (ESRD) on hemodialysis.