Tag: FDA
FDA Grants Approval to Johnson & Johnson’s IMAAVY for Warm Autoimmune Hemolytic Anemia
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY® (nipocalimab-aahu) as the first therapy specifically indicated for the...
FDA Approves Moderna’s mFLUSIVA, the First mRNA-Based Seasonal Influenza Vaccine
Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA (mRNA-1010), making it the first mRNA-based vaccine approved for seasonal influenza.
The vaccine...
FDA Reaches Out to Indian Pharma Amid Critical Ifosfamide Shortage in U.S.
A chemotherapy drug that stands between cancer patients and their treatment has gone dangerously scarce in the United States, compelling federal health regulators to...
FDA Grants Accelerated Approval to Sanofi’s Tzield® for Pediatric Stage 3 Type 1 Diabetes
The U.S. Food and Drug Administration has granted accelerated approval to Sanofi's Tzield® (teplizumab-mzwv) for children aged 8 to 17 years recently diagnosed with stage...
The FDA has outlined its updated strategy for generic drug oversight
The U.S. Food and Drug Administration (FDA) announced its modernized framework for generic drug oversight, highlighting a dual focus on enforcing rigorous quality standards...
