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.
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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 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 Greenlights BMS, J&J CAR-T Therapies
The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of…
FDA Signs Off on Adaptimmune’s Tecelra
Patients with a certain type of synovial sarcoma have a new treatment option for the first time in more than a decade as the…
Ferring Receives Approval from U.S. FDA for Adstiladrin
Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer.
