YD Bio Says FDA Agrees To Provide Written Guidance By January 4, 2027, To Support Development Of YDB-LMSCEV-001
Benzinga Newsdesk 2 days ago
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YD Bio Limited ("YD Bio" or the "Company") (NASDAQ:YDES), a biotechnology company advancing DNA methylation-based cancer detection and ophthalmologic innovations, today announced that the U.S. Food and
YD Bio Limited ("YD Bio" or the "Company") (NASDAQ:YDES), a biotechnology company advancing DNA methylation-based cancer detection and ophthalmologic innovations, today announced that the U.S. Food and Drug Administration (the "FDA") has granted its request for an INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting.
Through this program, the FDA will provide early written regulatory feedback on YDB-LMSCEV-001, the Company’s investigational biologic eye drop for moderate-to-severe dry eye disease. This early-stage product uses extracellular vesicles ("EVs"), naturally occurring particles derived from healthy donor eye stem cells specifically known as allogeneic human limbal mesenchymal stem cells ("LMSCs").
In a letter dated November 9, 2026, CBER (the FDA’s Center for Biologics Evaluation and Research) acknowledged receipt of the Company’s meeting request and briefing package submitted on October 21, 2026, and agreed to provide feedback via a Written Response Only format, with answers expected by January 4, 2027.