Ameluz-based photodynamic therapy achieved higher clearance rates in superficial basal cell carcinoma compared to placebo, with significant clinical and histological results. The study involved 187 ...
Phase 1 maximal-use pharmacokinetics (PK) study completed in support of planned U.S. label expansionData to complement previously announced ...
The FDA accepted the supplemental new drug application (sNDA) for aminolevulinic acid hydrochloride 10% topical gel (Ameluz) as part of photodynamic therapy (PDT) for superficial basal cell carcinoma ...
Phase 3 clinical trial results demonstrate that Ameluz photodynamic therapy is an effective treatment for actinic keratoses ...
The FDA has accepted a sNDA for Ameluz topical gel, used in combination with the RhodoLED red-light lamp series, for superficial basal cell carcinoma treatment.
Study findings met its primary endpoint and showed highly statistically significant superiority for Ameluz® vs. vehicle gel ...
WOBURN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of ...
WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of ...
Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026If approved, Ameluz® would be the first ...
WOBURN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of PDT, ...
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