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Aldeyra Therapeutics Gets CRL From FDA For NDA Of ADX-2191 To Treat Primary Vitreoretinal Lymphoma

Por: RTTNews Health June 21, 2023

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Biotechnology company Aldeyra Therapeutics, Inc. () announced Wednesday the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).Although no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there... + full article



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