Blog
RSS FeedPosted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 17 Jan 2025
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
16 January 2025 - Atara received FDA complete response letter solely related to inspection findings at third party manufacturer. ...
Posted by Michael Wonder on 09 Jan 2025
Marengo’s first in class invikafusp alfa (STAR0602) receives US FDA fast track designation for treatment of unresectable, locally advanced, or metastatic colorectal cancers with high tumour mutational burden
8 January 2025 - Initial safety and efficacy data from Phase 1 STARt-001 trial showed promising single agent clinical activity ...
Posted by Michael Wonder on 07 Jan 2025
Restem receives FDA fast track designation for Restem-L for idiopathic inflammatory myopathy
7 January 2025 - Second regulatory designation for Restem-L, a lead ULSC program, following the recent orphan drug designation. ...
Posted by Michael Wonder on 03 Jan 2025
Capricor Therapeutics completes submission of biologics license application to the US FDA for deramiocel for the treatment of Duchenne muscular dystrophy
2 January 2024 - If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy. ...
Posted by Michael Wonder on 22 Dec 2024
FDA approves first acellular tissue engineered vessel to treat vascular trauma in extremities
20 December 2024 - The US FDA approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as ...
Posted by Michael Wonder on 22 Dec 2024
BioGenCell receives FDA fast track designation with expanded access for BGC101
19 December 2024 - BioGenCell announced that the US FDA has granted fast track designation to its lead candidate, BGC101, ...
Posted by Michael Wonder on 19 Dec 2024
FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in paediatric patients
18 December 2024 - Today, the FDA approved remestemcel-L-rknd (Ryoncil, Mesoblast), an allogeneic bone marrow derived mesenchymal stromal cell therapy, ...
Posted by Michael Wonder on 12 Dec 2024
EpicentRx's oncolytic virus-delivered TGFβ Inhibitor, AdAPT-001, receives FDA fast track designation for recurrent or refractory soft tissue sarcoma treatment
5 December 2024 - EpicentRx announced today that the US FDA granted fast track designation for the oncolytic adenovirus-delivered transforming growth ...
Posted by Michael Wonder on 12 Dec 2024
FDA grants Revescor (rexlemestrocel-L) regenerative medicine advanced therapy designation in children with congenital heart disease
5 December 2024 - Earlier this year FDA granted Revascor both rare paediatric disease designation and orphan drug designation for ...
Posted by Michael Wonder on 06 Dec 2024
Sana Biotechnology announces fast track designation for SC291 in relapsed/refractory systemic lupus erythematosus
2 December 2025 - Enrolling patients in the GLEAM trial for SC291 in B-cell mediated auto-immune diseases, including systemic lupus erythematosus; ...
Posted by Michael Wonder on 12 Nov 2024
Neurotech provides update on BLA for NT-501 as a treatment for macular telangiectasia type 2
8 November 2024 - Neurotech Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date by three months ...
Posted by Michael Wonder on 08 Nov 2024
FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
8 November 2024 - Today, the FDA approved obecabtagene autoleucel (Aucatzyl, Autolus), a CD19 directed genetically modified autologous T cell ...
Posted by Michael Wonder on 29 Oct 2024
Allogene Therapeutics receives FDA regenerative medicine advanced therapy designation for ALLO-316, an AlloCAR T investigational product for adult patients with advanced or metastatic renal cell carcinoma
29 October 2024 - ALLO-316 was previously granted fast track designation in March 2022 by the US FDA. ...
Posted by Michael Wonder on 17 Sep 2024
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-ALLO1 to treat relapsed/refractory multiple myeloma
16 September 2024 - FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1. ...