Co-Diagnostics (CODX) FDA Approvals $1.00 -0.14 (-12.02%) As of 12:16 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsNews and TrendsOwnershipSEC Filings Co-Diagnostics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Co-Diagnostics (CODX). Over the past two years, Co-Diagnostics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Co-Dx™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Co-Dx™ FDA Regulatory Events Co-Dx™ is a drug developed by Co-Diagnostics for the following indication: PCR COVID-19 test instrument. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - June 2,2026Provided Update Drug: Co-Dx™Announced Date: June 2, 2026Indication: PCR COVID-19 test instrument AnnouncementCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV").AI SummaryCo-Diagnostics, Inc. said its joint venture, CoSara Diagnostics Pvt. Ltd., is making steady progress on an Ebola PCR development program. The company is working on a dual-assay strategy that could help both outbreak response and ongoing surveillance in affected regions. One possible test would use blood samples, which could expand the capabilities of Co-Dx’s PCR point-of-care platform. Co-Diagnostics said this approach may offer more flexibility for public health response efforts, including support for potential non-governmental organization partners. The project is still in development and will need validation, regulatory review, and future deployment steps before it can be used. The company said the effort is meant to improve readiness for Ebola response in areas that may need fast and reliable testing.Read Announcement Co-Diagnostics FDA Events - Frequently Asked Questions Has Co-Diagnostics received FDA approval? As of now, Co-Diagnostics (CODX) has not received any FDA approvals for its therapy in the last two years. What drugs has Co-Diagnostics submitted to the FDA? In the past two years, Co-Diagnostics (CODX) has reported FDA regulatory activity for Co-Dx™. What is the most recent FDA event for Co-Diagnostics? The most recent FDA-related event for Co-Diagnostics occurred on June 2, 2026, involving Co-Dx™. The update was categorized as "Provided Update," with the company reporting: "Co-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV")." What conditions do Co-Diagnostics' current drugs treat? Currently, Co-Diagnostics has one therapy (Co-Dx™) targeting the following condition: PCR COVID-19 test instrument. 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We continuously monitor for new FDA events and market data. 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Provided Update - June 2,2026Provided Update Drug: Co-Dx™Announced Date: June 2, 2026Indication: PCR COVID-19 test instrument AnnouncementCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV").AI SummaryCo-Diagnostics, Inc. said its joint venture, CoSara Diagnostics Pvt. Ltd., is making steady progress on an Ebola PCR development program. The company is working on a dual-assay strategy that could help both outbreak response and ongoing surveillance in affected regions. One possible test would use blood samples, which could expand the capabilities of Co-Dx’s PCR point-of-care platform. Co-Diagnostics said this approach may offer more flexibility for public health response efforts, including support for potential non-governmental organization partners. The project is still in development and will need validation, regulatory review, and future deployment steps before it can be used. The company said the effort is meant to improve readiness for Ebola response in areas that may need fast and reliable testing.Read Announcement
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