The FDA approved lisocabtagene maraleucel for treatment of adults with relapsed or refractory large B-cell lymphoma after one prior therapy. See all of Catapult's Regulatory Round-up for June 2022 here. Published on the 1st of July 2022
The FDA has approved an update to the voretigene neparvovec-rzyl (Luxturna) post-marketing experienc...
Tisagenlecleucel (tisa-cel) is a second-generation autologous CD19-targeted chimeric antigen recepto...
Non-Hodgkin Lymphoma accounts for >460,000 cases and >240,000 deaths globally and >77,000 cases and ...
The FDA has approved bluebird bio’s gene therapy betibeglogene autotemcel (beti-cel), now marketed a...
Background: Patients with relapsed or refractory large B-cell lymphoma after first-line treatment wh...
On November 15, 2018, the Committee for Medicinal Products for Human Use (CHMP) recommended the exte...
MabThera approved in Europe for use in patients with previously-treated chronic lymphocytic leukaemi...
Title Consultation Period Category Considerations for Rescinding Breakthrough Therapy Designat...
Background: Patients (pts) with aggressive large B-cell NHL who are R/R after first-line immunochemo...
Diffuse large B-cell lymphoma is an aggressive and biologically heterogeneous disease. R-CHOP is the...
Non-Hodgkin Lymphoma accounts for \u3e460,000 cases and \u3e240,000 deaths globally and \u3e77,000 c...
Background: Patients with diffuse large B-cell lymphoma that is refractory to primary and secondline...
Signed into law in 2016, the 21st Century Cures Act offers new hope to patients by empowering the FD...
Novel immunotherapeutic approaches to the treatment of diffuse large B-cell lymphoma (DLBCL), includ...
Human Gene Therapy Products Incorporating Human Genome Editing End Date: 14 Jul 2022 Draft Guidance ...
The FDA has approved an update to the voretigene neparvovec-rzyl (Luxturna) post-marketing experienc...
Tisagenlecleucel (tisa-cel) is a second-generation autologous CD19-targeted chimeric antigen recepto...
Non-Hodgkin Lymphoma accounts for >460,000 cases and >240,000 deaths globally and >77,000 cases and ...
The FDA has approved bluebird bio’s gene therapy betibeglogene autotemcel (beti-cel), now marketed a...
Background: Patients with relapsed or refractory large B-cell lymphoma after first-line treatment wh...
On November 15, 2018, the Committee for Medicinal Products for Human Use (CHMP) recommended the exte...
MabThera approved in Europe for use in patients with previously-treated chronic lymphocytic leukaemi...
Title Consultation Period Category Considerations for Rescinding Breakthrough Therapy Designat...
Background: Patients (pts) with aggressive large B-cell NHL who are R/R after first-line immunochemo...
Diffuse large B-cell lymphoma is an aggressive and biologically heterogeneous disease. R-CHOP is the...
Non-Hodgkin Lymphoma accounts for \u3e460,000 cases and \u3e240,000 deaths globally and \u3e77,000 c...
Background: Patients with diffuse large B-cell lymphoma that is refractory to primary and secondline...
Signed into law in 2016, the 21st Century Cures Act offers new hope to patients by empowering the FD...
Novel immunotherapeutic approaches to the treatment of diffuse large B-cell lymphoma (DLBCL), includ...
Human Gene Therapy Products Incorporating Human Genome Editing End Date: 14 Jul 2022 Draft Guidance ...
The FDA has approved an update to the voretigene neparvovec-rzyl (Luxturna) post-marketing experienc...
Tisagenlecleucel (tisa-cel) is a second-generation autologous CD19-targeted chimeric antigen recepto...
Non-Hodgkin Lymphoma accounts for >460,000 cases and >240,000 deaths globally and >77,000 cases and ...