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OpGen Submits De Novo request to the U.S. FDA for Unyvero Urinary Tract Infection Panel
April 18, 2023 07:30 ET | OpGen, Inc.
Based on large multi-center study with over 1,800 patient samplesPrimary endpoint for Unyvero UTI for urinary tract infection was successfully met and shows overall weighted average sensitivity of...
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Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S. FDA for ACER-001 for Treatment of Urea Cycle Disorders
August 09, 2021 08:30 ET | Acer Therapeutics Inc.
NEWTON, Mass. and GENEVA, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”), a pharmaceutical company focused on the acquisition, development and commercialization of...