The company said the feedback will help it finalize manufacturing and preclinical plans ahead of a formal pre-Investigational New Drug meeting, a key regulatory step before human trials. YD Bio is a biotechnology firm focused on cancer detection and eye treatment.
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FDA to Provide YD Bio Feedback on Investigational Dry-Eye Drop
YD Bio said the FDA has agreed to provide written regulatory feedback on its investigational biologic eye drop for moderate-to-severe dry eye disease, with a response expected by Jan. 4, 2027.
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