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  1. www.fdatracker.com › fda-calendarFDA Calendar – FDA Tracker

    Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers companies publicly traded in the U.S. facing upcoming PDUFA dates.

    • Trial Tracker

      Trial Tracker Demo. This limited demo only displays Phase 3...

  2. biopharmawatch.com › fda-calendarFDA Calendar - BioPharmaWatch

    Our Free FDA Calendar is a daily updated tool that tracks future catalysts and key dates across biotech and pharma companies, including clinical trials, regulatory events, and PDUFA dates, designed to inform on stock-moving events

  3. www.rttnews.com › corpinfo › fdacalendarFDA Calendar, FDA Drug Approval, PDUFA Calendar - RTTNews

    Get daily updates on important FDA approval, PDUFA dates, and FDA Advisory Committee Meetings with RTTNews FDA Calendar & Upcoming Approvals.

  4. www.fda.gov › drugs › nda-and-bla-approvalsNDA and BLA Calendar Year Approvals | FDA

    2 Μαρ 2023 · CDER Drug and Biologic Approvals for Calendar Year 2020. CDER Drug and Biologic Approvals for Calendar Year 2019. CDER Drug and Biologic Approvals for Calendar Year 2018. CDER Drug and Biologic ...

  5. s3-us-west-2.amazonaws.com › drugbank › cite_thisexanta (ximelagatran) tablets nda 21-686 fda advisory committee...

    EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 2 EXECUTIVE SUMMARY New Drug Application (NDA) 21-686, submitted by AstraZeneca LP (AstraZeneca), requests approval for the use of EXANTA® (ximelagatran) Tablets as: œ An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention

  6. www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee...

    New Drug Application (NDA) 21-686, submitted by AstraZeneca LP (AstraZeneca), requests approval for the use of EXANTA® (ximelagatran) Tablets as: An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute VTE An oral 36-mg bid fixed dose ...

  7. www.drugs.com › history › exantaExanta (ximelagatran): What is it and is it FDA approved ... -...

    Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation. Exanta (ximelagatran) is an investigational oral direct thrombin inhibitor (oral DTI) intended for use in the prevention of strokes in patients with atrial ...

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