UPDATED AUGUST 31 // The first T-cell therapy that uses chimeric antigen receptor (CAR) technology has been approved today by the US Food and Drug Administration (FDA), paving the way for the other products using this novel approach that are in development. "We're entering a new frontier ...
Ok! The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel [liso-cel]) as the first CD19-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small l...
The article reports on the clinical trial that will be launched by Bioheart to test a combination gene and stem cell therapy for congestive heart failure (CHF). According to Bioheart, a phase I trial for Myocell Stroma Derived Factor-1 (SDF-1) to treat CHF has been approved by the U....
The FDA gave the green light to Novartis's tisagenlecleucel for the treatment of acute lymphoblastic leukaemia (ALL), marking a historic approval for a first-in-modality chimeric antigen receptor (CAR) T cell therapy. CAR Ts are an ex vivo form of gene therapy, in which T cells are rem...
Fosun Kite Biotech was founded in 2017 in Shanghai, aiming to develop immune cell therapy products. Yescarta is its first commercialized product. The FDA approved Yescarta for treating adults with certain types of large B-cell lymphoma in the US in October 2017,the first approval for this produ...
BMS’ Abecma Becomes First CAR T Cell Therapy Approved in the EU for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma
Officials with the FDA have approved capmatinib (Tabrecta, Novartis Pharmaceuticals) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Capmatinib is the first FDA-approved therapy to treat NSCLC with specific mutations (those ...
FDA approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy
Lantidra is an FDA-approved allogeneic cellular therapy derived from donor pancreatic islet cells. Compared to whole pancreas transplantation, administration of Lantidra (minimum dosage: 5,000 islet equivalent/kg body weight) into the hepatic portal vein via percutaneous or transvenous transhepatic ...
The U.S. Food and Drug Administration (FDA) has cleared the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. Ad The approval is for Rejoyn, a six-week treatment program that can enhance cognitive control of emotion as an...