BFRI PDUFA Date: Ameluz Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Sep 28, 2026 · Biofrontera Inc. · Basal cell carcinoma
Key facts FDA PDUFA target date 2026-09-28
Drug / candidate Ameluz (aminolevulinic acid hydrochloride)
Indication Basal cell carcinoma
Company Biofrontera Inc.
Market-cap tier Nano
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All September 2026 PDUFA dates → FAQ When is the BFRI PDUFA date? The FDA PDUFA target date for BFRI (Biofrontera Inc.) is 2026-09-28 for Ameluz (aminolevulinic acid hydrochloride). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BFRI's drug Ameluz? Ameluz (aminolevulinic acid hydrochloride) is Biofrontera Inc.'s candidate under FDA review for Basal cell carcinoma.
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