Approval provides early access to therapy while clinical trials continue. The U.S. Food and Drug Administration (FDA) recently approved Amtagvi (lifileucel) as the first cellular therapy for adults…
Read MoreCenter for Biologic Evaluation and Research
FDA Approves Gene Therapies for Sickle Cell Disease
Two cell-based gene therapies will address the debilitating hereditary blood disorder. The U.S. Food and Drug Administration (FDA) has granted approval of two groundbreaking cell-based gene therapies, Casgevy…
Read More
FDA Approves New Treatment for Rare Blood Clotting Disorder
Director Marks announced the therapy for the life-threatening disorder. The U.S. Food and Drug Administration recently approved Adzynma for patients with congenital thrombotic thrombocytopenic purpura (cTTP). The genetically…
Read More
FDA Warns of Probiotic Risks for Preterm Infants
The agency encourages reporting of illegally marketed substances. The U.S. Food and Drug Administration (FDA) has issued a warning for the public and healthcare providers regarding the risks…
Read MoreFDA Approves Cell Therapy for Blood Cancer Patients
Cell therapy has the potential to reduce the risk of infection after stem cell transplants. The U.S. Food and Drug Administration (FDA) recently approved Omisirge (omidubicel-onlv), a donor-modified…
Read More