Immune Disorders Archives

FDA Greenlights Enzyvant Drug for Ultra-Rare Pediatric Disease

Approvals, Children, Complete Response Letter, FDA/Regulatory, Immune Disorders, Pediatric Congenital Athymia, T-Cells, Therapeutics, Ultra Rare Diseases

The U.S. Food and Drug Administration approved Enzyvant Sciences’s Rethymic (allogeneic processed thymus tissue-agdc) for children with congenital athymia.

Enzyvant Resubmits BLA for Pediatric Congenital Athymia Drug

Biologics License Application (BLA), BLA Resubmission, Complete Response Letter, FDA, Immune Disorders, PDUFA, Pediatric, Pediatric Congenital Athymia, Regenerative Tissue, Reuters

Enzyvant Sciences resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the company’s tissue-based regenerative pediatric congenital athymia therapy RVT-802.

Some Studies Suggest IV Immunoglobulin Could Help Treat COVID-19

Blood Plasma, Coronavirus Disease 2019 (COVID-19), Immune Disorders, Intravenous Immunoglobulin (IVIg), Physicians, R&D, Researchers, Studies

As researchers and physicians try to identify ways to effectively treat and prevent COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, some are studying whether high-dose intravenous immunoglobulin (IVIg) could work. IVIg is a common blood plasma product that is used to treat other immune disorders.