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ClinicalTrials.gov identifiers NCT01037582, NCT01686945

Among the 17 BLAs cleared by CBER in 2024, six were orphan designated

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Ex vivo skin penetration analysis by fluorescence and confocal observation of histological skin sections revealed the ability of BSA/HA nanodispersions to cross the stratum corneum and penetrate the dermis [76]

However, more recent observations from numerous case reports (summarized below) suggest that the risk of permanent injury is relatively low