Aldeyra Therapeutics provides regulatory update on ADX-2191

Aldeyra Therapeutics

21 June 2023 - Based on US FDA determination of lack of adequate and well controlled investigations in the scientific literature, complete response letter received for new drug application of ADX-2191 (methotrexate) for the treatment of primary vitreoretinal lymphoma.

Aldeyra today announced receipt of a complete response letter from the US FDA for the new drug application of ADX-2191 (methotrexate), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma.

Read Aldeyra Therapeutics press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier