Biofrontera Inc. Announces FDA Filing of Supplemental New Drug Application for Ameluz(R) to Permit Up to Three Tubes Per Use [Yahoo! Finance]
Biofrontera Inc. (BFRI)
Company Research
Source: Yahoo! Finance
An estimated 13 million treatments given each year for AK in the US WOBURN, MA / ACCESSWIRE / February 5, 2024 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company") , a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that the U.S. Food and Drug Administration (FDA) has issued a " no filing review issues identified" letter regarding the sNDA (supplementary New Drug Application) submitted by its licensor Biofrontera Bioscience GmbH to increase the maximally approved dosage from one to three tubes of Ameluz ® per treatment. FDA has completed its filing review and will begin its substantive review of Biofrontera's communication. "The studies supporting this application showed robust safety parameters for the simultaneous use of three tubes, with systemic and application site adverse events equivalent to those with one tube," stated Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. "Many pat
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News
- Biofrontera Announces Achievement of Two Milestones Associated with Series B-3 Convertible Preferred Stock Warrants [Yahoo! Finance]Yahoo! Finance
- Biofrontera Announces Achievement of Two Milestones Associated with Series B-3 Convertible Preferred Stock WarrantsAccesswire
- Biofrontera Inc. Announces 2024 Annual Meeting of Stockholders and Deadlines for Submission of Stockholder Proposals [Yahoo! Finance]Yahoo! Finance
- Biofrontera Inc. Announces 2024 Annual Meeting of Stockholders and Deadlines for Submission of Stockholder ProposalsAccesswire
- Biofrontera Inc. (NASDAQ:BFRI) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
BFRI
Earnings
- 11/9/23 - Beat
BFRI
Sec Filings
- 5/3/24 - Form 8-K
- 5/3/24 - Form S-1
- 4/30/24 - Form 8-K
- BFRI's page on the SEC website