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By Will Feuer Aldeyra Therapeutics said it has received a complete response letter from the U.S. Food and Drug Administration that said there was a lack of...
Biotechnology company Aldeyra Therapeutics, Inc. (ALDX) 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).
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
Q1/23 Talicia net revenues of $3.4 million; Cash balance of $28.8 million as of March 31, 2023[1]; Extinguishment of all debt obligations in exchange for the...
Real-World Results Demonstrate Objective Response Rate of 67% in 24 EBV+ PTLD Patients 91% Overall Survival at One Year for Patients Responding to Tab-cel Compared to 34% for... | June 5, 2023