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NX Development Corp. Awarded Orphan-Drug Designation for Gleolan in Ovarian Cancer Treatment
NX Development Corp. (NXDC) announces a significant regulatory milestone with the U.S. Food and Drug Administration (FDA)'s grant of orphan-drug status for its product, Gleolan (aminolevulinic acid HCl). This marks a notable advancement in the treatment of ovarian and related cancers, specifically targeting the real-time detection and visualization of epithelial ovarian tumors during debulking surgery.
Dr. Salvatore DeSena, CEO of NXDC, expressed pride in the achievement, highlighting its reflection on the company's dedication to enhancing surgical outcomes for patients battling ovarian, fallopian tube, and primary peritoneal cancer. This development reinforces Gleolan's role in fluorescence-guided surgery, offering new avenues for surgical precision and improved patient care.
Chairman Dr. Ulrich Kosciessa underscored the importance of this milestone, indicating plans to extend the application of aminolevulinic acid HCl in fluorescence-guided surgery beyond the U.S., aiming to support healthcare professionals and patients globally. Gleolan is already acknowledged within the medical community for its efficacy in visualizing malignant glioma tissue, with the new designation expanding its potential therapeutic utility in cancer surgery.
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