6 December 2023 - First BLA for an engineered T-cell therapy for solid tumours submitted to US FDA. ...
30 November 2023 - Previously reported results from ongoing proof of concept study showed extensive metabolic correction, continued cognitive, motor, and ...
28 November 2023 - The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR positive lymphoma, in ...
27 November 2023 - Sernova today announced the US FDA has granted both orphan drug designation and rare paediatric disease designation ...
27 November 2023 - BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory adult B-cell acute ...
27 November 2023 - Pivotal Phase 3 study of olvi-vec in platinum resistant/refractory ovarian cancer initiated in September 2022. ...
20 November 2023 - Bristol Myers Squibb and 2seventy bio today announced the US FDA Oncologic Drugs Advisory Committee will ...
20 November 2023 - Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people ...
9 November 2023 - Application based on results from TRANSCEND CLL 004, the first pivotal multi-centre trial to show clinical benefit ...
24 October 2023 - Regulatory activities underway with an initial focus on a registration directed trial in melanoma as step ...
19 October 2023 - Aspen Neuroscience today announced that the US FDA has granted fast track designation for ANPD001 for the ...
18 October 2023 - Biologics license application to be withdrawn without prejudice. ...
17 October 2023 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the Company’s unique ...
16 October 2023 - Editas Medicine today announced that the US FDA granted regenerative medicine advanced therapy designation to EDIT-301, an ...
10 October 2023 - IMPT-514 is the first CD19/CD20 CAR T-cell therapy in development for lupus. ...