FDA Approves Aucatzyl for Adults with Aggressive Leukemia
Aucatzyl is a CAR T-cell therapy that targets CD19 and has been designed to minimize excessive activation of the programmed T cells. The wholesale…
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FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
FDA Approves Krystal Gene Therapy For Rare Wound Disorder
The Food and Drug Administration on Friday approved the first topical gene therapy, clearing a treatment developed by Krystal Biotech for a rare genetic skin…
FDA Approves Mesoblast’s First-Of-Its-Kind Cell Therapy
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
FDA Approves the First Pediatric Gene Therapy for MPS IIIA
A monumental milestone for children and families impacted by Sanfilippo syndrome Type A (MPS IIIA): The FDA has granted full approval to FAYUVI™ (rebisufligene…
FDA Approves World’s First CRISPR-Based Medicine For Sickle Cell
The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers…
FDA Blesses CellTrans’ Lantidra
Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. But flying under the radar with…
FDA Expands Approval of Vertex’s CRISPR Gene-editing Therapy, Casgevy.
FDA expanded the approval of Vertex’s CRISPR gene-editing therapy, Casgevy, down to pediatric patients 2 years and older for both severe sickle cell disease…
