Biofrontera 获得 FDA 批准，增加 Ameluz 外用凝胶剂量，用于治疗面部和头皮的光化性角化病。 Biofrontera receives FDA approval to increase Ameluz topical gel dosage for actinic keratosis treatment on face and scalp.
Biofrontera Inc. 已获得 FDA 批准，将其 Ameluz 外用凝胶的最大剂量从每次治疗面部和头皮光化性角化病 （AK） 的 1 管增加到 3 管。 Biofrontera Inc. has received FDA approval to increase the maximum dosage of its Ameluz topical gel from one to three tubes per treatment for actinic keratosis (AK) on the face and scalp. 这项决定基于第一阶段的两个安全研究,涉及116名病人,允许使用Ameluz-PDT用特定灯具进行更大的地区治疗。 This decision, based on two Phase I safety studies involving 116 patients, allows for larger area treatment using Ameluz-PDT with specific lamps. 该公司现在将与医疗保险公司和商业付款人就这一最新情况的偿还问题进行接触。 The company will now engage with Medicare and commercial payers regarding reimbursement for this update.