Abeona therapeutics announces fda accepts and grants priority review for pz-cel biologics license application (bla)

- pdufa target action date is may 25, 2024 - - fda does not currently plan to hold advisory committee meeting for pz-cel bla - cleveland, nov. 27, 2023 (globe newswire) -- abeona therapeutics inc. (nasdaq: abeo) today announced that the u.s. food and drug administration (fda) has accepted and granted priority review for the biologics license application (bla) for pz-cel (prademagene zamikeracel), abeona's investigational autologous, col7a1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa (rdeb). under the prescription drug user fee act (pdufa), the fda has set a target action date of may 25, 2024.
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