FDA Approves First Oral Medication for Lupus Nephritis

FDA Approves First Oral Medication for Lupus Nephritis

The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune...
FDA Releases AI/ML Five-Part Action Plan for SaMD

FDA Releases AI/ML Five-Part Action Plan for SaMD

The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...