Blog
RSS FeedPosted by Michael Wonder on 11 Feb 2025
Immix Biopharma receives FDA regenerative medicine advanced therapy designation for NXC-201, sterically optimised CAR-T for relapsed/refractory AL amyloidosis
10 February 2025 - FDA RMAT designation follows positive proof of concept US clinical data from the NXC-201 NEXICART-2 clinical trial ...
Posted by Michael Wonder on 06 Feb 2025
Gradalis secures FDA regenerative medicine advanced therapy designation for Vigil (gemogenovatucel-T): an investigational personalised immunotherapy for advanced ovarian cancer
5 February 2025 - Recognising clinical evidence from the Phase 2b VITAL Study of Vigil in homologous recombination proficient patients with ...
Posted by Michael Wonder on 05 Feb 2025
Adicet Bio receives FDA fast track designation for ADI-001 for the treatment of refractory systemic lupus erythematosus with extra-renal involvement
5 February 2025 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the ...
Posted 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 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
31 January 2025 - Recommendation based on the Phase 2 TRANSCEND FL study in which 97.1% of patients responded to Breyanzi, ...
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 14 Jan 2025
CAR T cell therapy Breyanzi (lisocabtagene maraleucel) approved for second-line relapsed or refractory diffuse large B-cell lymphoma
13 January 2024 - In the pivotal Phase 3 TRANSFORM trial, Breyanzi demonstrated a significant improvement in event-free survival over ...
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 17 Dec 2024
ICER publishes final evidence report on treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease
16 December 2024 - Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ...
Posted by Michael Wonder on 14 Dec 2024
Alofisel withdrawn from the EU market
13 December 2024 - Benefit of treatment used in Crohn’s disease no longer demonstrated. ...