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FDA Accepts Atara Biotherapeutics Resubmission of BLA for Tabelecleucel January 5, 2026 Ultragenyx has completed its submission of a rolling BLA to the FDA for DTX401, an investigational AAV serotype 8 (AAV8) vector gene therapy expressing the human G6PC gene that is intended to treat Glycogen Storage Disease Type Ia (GSDIa)
The FDA's 503A Bulks List identifies bulk drug substances that may be used by licensed 503A compounding pharmacies in preparing customized medications for individual patients pursuant to a valid prescription, subject to applicable statutory and regulatory requirements
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