Biofrontera Reports FDA Filing Of Supplemental New Drug Application For Ameluz To Permit Up To Three Tubes Per Use; FDA Has Set Target Action Date Of October 4, 2024
Portfolio Pulse from Benzinga Newsdesk
Biofrontera has announced the FDA's acceptance of a supplemental new drug application for Ameluz, allowing up to three tubes per use. The FDA has set a target action date of October 4, 2024.
February 05, 2024 | 10:19 pm
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Biofrontera's supplemental new drug application for Ameluz has been accepted by the FDA, potentially allowing up to three tubes per use with a decision expected by October 4, 2024.
The FDA's acceptance of Biofrontera's supplemental new drug application for Ameluz represents a significant regulatory milestone. If approved, this could lead to increased usage and sales of Ameluz, positively impacting Biofrontera's financial performance and potentially its stock price in the short term. The high relevance score reflects the direct impact on Biofrontera, while the importance score indicates the potential for significant financial implications. The confidence level is set at 75 due to the inherent uncertainties in regulatory approval processes.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 90