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  1. 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 of venous thromboembolism (VTE) after standard treatment for an episode of acute

  2. 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 ...

  3. 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.

  4. This report reflects the data shown as it is identified in the database. Selection Criteria: User Response: Start Date: 1/1/2023 End Date: 12/31/2023. Sort Order: Approval Date.

  5. Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation.

  6. 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

  7. 29 Ιουλ 2024 · The table below is a running list of CDER’s novel drugs approvals for 2024. Export Excel. Showing 1 to 23 of 23 entries. *The listed “FDA-approved use” on this website is for presentation...

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