PDUFAApproval decision
Ameluz®-PDT combo w/ BF-RhodoLED®
Superficial basal cell carcinoma
BFRIBiofronteraExpected catalystSeptember 28, 2026Company guidance: Sep 28, 2026
Catalyst overview
Event details
- Drug or asset
- Ameluz®-PDT combo w/ BF-RhodoLED®
- Development stage
- PDUFA
- Event type
- Approval decision
- Indication
- Superficial basal cell carcinoma
Research summary
What is being tracked?
This catalyst tracks a PDUFA approval decision for Ameluz®-PDT combo w/ BF-RhodoLED® in Superficial basal cell carcinoma. The expected timing is based on the latest available company guidance and may change.
Development notes
05/14/26:- sBCC sNDA acceptance and September 28, 2026 PDUFA date reiterated. 08/13/26:- PDUFA decision remains due September 28, 2026. Launch is expected in Q1 2027 if approved.
Verification
Primary source
Confirm timing and program details against the company announcement or filing.