Ameluz (aminolevulinic acid hydrochloride) is a Biofrontera Inc. program in Superficial basal cell carcinoma (sBCC), photodynamic therapy with the RhodoLED lamp series. The FDA approved it on Sep 9, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Superficial basal cell carcinoma (sBCC), photodynamic therapy with the RhodoLED lamp series. Sponsor: Biofrontera Inc. (BFRI). Review status: The FDA approved Ameluz photodynamic therapy with red light for superficial basal cell carcinoma, making it the first photodynamic therapy approved in the United States to treat a skin cancer. The FDA's action date is September 9, 2026 (openFDA records the efficacy supplement as approved that day), 19 days before the September 28 goal date Biofrontera had stated, but Biofrontera did not announce it until September 14 -- so any share-price move dates from the announcement, not from the FDA's action. Market-cap tier at the time we tracked it: Nano. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for Ameluz (aminolevulinic acid hydrochloride); 1 FDA decision is on record below.
On Sep 9, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Ameluz (aminolevulinic acid hydrochloride) is under review or in development for Superficial basal cell carcinoma (sBCC), photodynamic therapy with the RhodoLED lamp series.
Biofrontera Inc. (BFRI).
Yes. The FDA approved an application for Ameluz (aminolevulinic acid hydrochloride) on Sep 9, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.