Biofrontera Inc.
Ameluz
superficial basal cell carcinoma (sBCC)
Date
TBD
FDA decision · Date TBD estimated
What's at stake
An FDA complete response letter on Ameluz for superficial basal cell carcinoma (sBCC) is in focus around Date TBD.
Primary source
· SEC 8-K
verified 15h ago
“Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz ® Photodynamic Therapy (PDT) for the treatment of superficial basal cell carcinoma (sBCC).”