Biofrontera submits supplemental NDA to expand Ameluz for full-body AK
Biofrontera said it has submitted a supplemental new drug application to the FDA to expand Ameluz® Red Light PDT for actinic keratoses on the full body.
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01:27:58 PM UTC
SquawkNews
Biofrontera submitted an sNDA to the FDA to expand Ameluz red-light PDT for mild-to-moderate AKs to extremities, neck and trunk, with an adjusted illumination protocol. FDA will first conduct a 60-day filing review.Material DetailsContext by AI AnalystThis is a mid-cycle regulatory step building on…