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Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Markets GlobeNewswire By GlobeNewswire 30 Jun 2026 11:05 1 min read
Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor -- -- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

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