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Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2Completion of this study marks a key milestone...
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sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025First Phase 3 PDT study in patients with sBCC in the United States submitted to...
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Proceeds of up to $10 million, consisting of $3 million at closing, $1 million upon availability of commercial product, and up to $6 million in sales-related milestone payments. Transaction further...
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Biofrontera Inc. acquires full U.S. rights to Ameluz® and RhodoLED®, including New Drug Application and associated patents, from former parent Biofrontera AG.New earnout structure reduces payment rate...
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WOBURN, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization...
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Final patient visit marks key milestone for Biofrontera, with top-line results expected Q1 2026Company plans FDA discussion in Q3 2026 to advance Phase 3 program and potential label expansionMore than...
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Woburn, MA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (the “Company”), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy...
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Biofrontera Inc. has signed an agreement to acquire all US assets related to Ameluz® and RhodoLED® including New Drug Application (NDA) and associated patents from Germany-based Biofrontera AG.Under...
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WOBURN, Mass., June 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), confirms...
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Biofrontera received patent approval for the revised formulation of Ameluz® in April 2025, extending patent protection through to December 2043.The Orange Book is published by the U.S. Food and Drug...