FDA Drug Approvals Highlights SPT Week in Review

5. FDA Approves Revisions to Epclusa Label to Include Co-Infection Clinical Trial Data

The label has been updated to include data from adults co-infected with hepatitis C virus and HIV-1. Read more…

4. FDA Grants Durvalumab Breakthrough Therapy Designation for Locally-Advanced Lung Cancer

Durvalumab is indicated to treat patients with locally-advanced, unresectable non-small cell lung cancer. Read more…

3. FDA Approves First Treatment for High-Risk Acute Myeloid Leukemia

Vyxeos is indicated to treat newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. Read more…

2. FDA Approves Opdivo for Additional Indication in Colon Cancer

Nivolumab approved for form of metastatic colorectal cancer that typically does not respond to chemotherapy. Read more…

1. FDA Approves Mavyret to Treat All Major Hepatitis C Genotypes

Combination therapy cuts standard HCV treatment regimen from 12 weeks to 8 weeks. Read more…