FDA Watch: Key Decisions for ImmunityBio, Aquestive, XOMA in April


The Food and Drug Administration (FDA) is set to conclude April with five target action dates for various indications, including treatments for pediatric seizures and a rare neurological cancer affecting children. Among the companies awaiting FDA decisions are ImmunityBio, Aquestive Therapeutics, and XOMA Corporation.

ImmunityBio is seeking approval for its antibody cytokine fusion protein, N-803, as a treatment for pediatric neuroblastoma, while Aquestive Therapeutics anticipates a decision on its diazepam buccal film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in epilepsy patients. XOMA Corporation is also awaiting a decision on its monoclonal antibody, gevokizumab, for the treatment of congenital hyperinsulinism.

These upcoming FDA actions highlight the agency’s ongoing efforts to review and approve innovative therapies for rare and severe conditions affecting pediatric populations. The outcomes of these decisions could potentially provide new treatment options for patients and their families facing challenging medical circumstances.