Phase 1 maximal-use pharmacokinetics (PK) study completed in support of planned U.S. label expansion Data to complement previously announced positive Phase 3 efficacy results on extremities, neck and...
Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026 If approved, Ameluz ® would be the first and only PDT photosensitizer indicated for the treatment of superficial...
Study findings met its primary endpoint and showed highly statistically significant superiority for Ameluz ® vs. vehicle gel (p
Fourth quarter results represent highest quarterly revenue in Company’s history Q4 year-over-year growth of 35% to 39% driven by sales execution of Ameluz ® Full year 2025 revenues also expected...
Database locks for studies on actinic keratosis (AK) and acne vulgaris achieved on January 5, 2026 Data generated will support key regulatory milestones for Ameluz PDT in both indications AK and...
• Ameluz ® and RhodoLED ® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc. • Assignment to Biofrontera...
Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz ® over treatment area of 240 cm 2 Completion of this study marks a key milestone...
sNDA for treatment of sBCC with Ameluz ® -PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to...
Conference call will be held today, Thursday, November 13 at 10:00 am ET Woburn, MA, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company...
WOBURN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company") , a biopharmaceutical company specializing in the commercialization of dermatological...