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Aldeyra Therapeutics (ALDX) Receives CRL from FDA for ADX-2191

Aldeyra Therapeutics (ALDX) Receives CRL from FDA for ADX-2191
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Aldeyra Therapeutics Provides Regulatory Update on ADX-2191

Based on U.S. Food & Drug Administration (FDA) Determination of Lack of Adequate and Well Controlled Investigations in the Scientific Literature, Complete Response Letter Received for New Drug Application (NDA) of ADX-2191 (methotrexate injection, USP) for the Treatment of Primary Vitreoretinal Lymphoma (PVRL)

Due to Shortage of Methotrexate, Lack of Approved Therapy for PVRL, and Inbound Requests for ADX-2191, Expanded Access Program Planned to be Discussed with FDA ....

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Aldeyra Therapeutics (ALDX) Receives CRL from FDA for ADX-2191

Aldeyra Therapeutics (ALDX) Receives CRL from FDA for ADX-2191
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

Ptoddc Brady , Access Program , Drug Administration , Complete Response Letter , New Drug Application , Chief Executive Officer , Expanded Access Program ,

Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis

Statistical Significance Achieved for Primary Endpoint of Ocular Itching at All Prespecified Timepoints

Statistical Significance Achieved for Key Secondary Endpoint of Ocular Redness. | June 15, 2023 ....

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Reproxalap demonstrates safety in dry eye trial, with visual acuity improvement

Treatment-related serious adverse events in ocular safety, the primary endpoints in a 12-month safety clinical trial of reproxalap for the treatment of dry eye disease, were not observed, according to an Aldeyra Therapeutics press release. ....

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