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Biofrontera submits FDA application to expand Ameluz PDT use for actinic keratoses on full body.

Market News
08 Oct 2026
GlobeNewsWire
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Bullish
Biofrontera submits FDA application to expand Ameluz PDT use for actinic keratoses on full body.

Biofrontera Inc. has submitted a supplemental New Drug Application to the FDA seeking approval to expand the use of its Ameluz® red light photodynamic therapy (PDT) from treating actinic keratoses (AKs) on the face and scalp to include mild-to-moderate AKs on the extremities, neck, and trunk. This expansion would make Ameluz® the only FDA-approved PDT treatment for AKs on the full body if approved. The submission is supported by positive Phase 3 trial results showing significant clearance of AK lesions and favorable cosmetic outcomes. Approval would allow dermatologists to treat a broader range of patients using the same product and equipment, potentially accelerating Biofrontera's revenue growth.

Biofrontera's supplemental New Drug Application to the FDA aims to expand Ameluz® red light PDT treatment to actinic keratoses on the full body. For readers following health-sector stocks, here is Pluang's market snapshot as of Oct 08, 2026 19:42 WIB: out of 128 priced health-sector US stocks, 34 rose and 88 fell. Notable movers include ABEO at USD 5.18 with 100% buy order activity, NVAX at USD 11.00 with 79% sell order activity, and ALNY at USD 220.02 with 92% sell order activity.

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