Source link : https://www.newshealth.biz/health-news/fda-seeks-more-information-about-rdeb-rx-under-review/
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), requesting more information from the manufacturer. Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated […]
Author : News Health
Publish date : 2024-04-25 13:28:47
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