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Onco-Summaries: Daily Oncology Updates at a Glance

11/02/2026















Biofrontera's sNDA for Ameluz® PDT in Superficial Basal Cell Carcinoma has been accepted by the US FDA (Ref)


The US FDA completed its filing review and accepted filing of Biofrontera's supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED® red-light lamp series for the treatment of Superficial Basal Cell Carcinoma.


  • The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026





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