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Here at PharmaTell, we have Eyes on FDA Approvals for 2025. Below, we share the monthly Novel Drug and Biologic License Application Approvals as listed on the FDA website. Many of the companies/products are covered in the PharmaTell Database. If you need additional details, search the company catalog and add the product name for research specifically on that therapy. We will publish the updated lists monthly.
January 2025 Novel Drug Approvals
Note: Updated with FDA website details for Novel Drug Approvals: Grafapex, Journavx, and Datroway approvals.
Approval Date | Drug Name | Active Ingredient | FDA-approved use on approval date* | Company |
1/17/2025 | Datroway | datopotamab deruxtecan-dlnk | To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease | Daiichi Sankyo marketed with AstraZeneca |
1/21/2025 | Grafapex | treosulfan | For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome | medac GmbH |
1/30/2025 | Journavx | suzetrigine | To treat moderate to severe acute pain | Vertex Pharmaceuticals |
Source: FDA Website - Novel Drug Approvals here,
January 2025 Biologic License Application Approvals
The FDA website showed no new entries for January on the BLA approvals list.
Tradename/ Proper Name | Indication for Use | STN | Manufacturer/License Number | Approval Date |
No BLA approvals noted for January 2025 |
Source: FDA Website - Biologic License Application approvals here.
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