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RSS FeedPosted by Michael Wonder on 21 Mar 2025
Secretome Therapeutics granted FDA fast track designation for STM-01, a neonatal cardiac progenitor cell therapy for HFpEF
20 March 2025 - Secretome Therapeutics today announced that the US FDA has granted fast track designation to STM-01, the company’s ...
Posted by Michael Wonder on 20 Mar 2025
Azercabtagene zapreleucel granted FDA fast track designation in blood cancer DLBCL
19 March 2025 - Imugene is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 17 Mar 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
14 March 2025 - In the TRANSCEND FL trial, 97.1% of patients responded to Breyanzi , with 94.2% of patients achieving ...
Posted by Michael Wonder on 05 Mar 2025
Capricor Therapeutics announces FDA acceptance and priority review of its biologics license application for deramiocel to treat Duchenne muscular dystrophy
4 March 2025 - FDA assigns PDUFA target action date of 31 August 2025. ...
Posted by Michael Wonder on 03 Mar 2025
Avobis Bio receives FDA fast track designation for AVB-114 implantable cell therapy for Crohn's perianal fistulas
27 February 2025 - Only implantable cell therapy for Crohn's perianal fistulas with FDA IND clearance and fast track designation. ...
Posted by Michael Wonder on 27 Feb 2025
BlueRock Therapeutics receives FDA fast track designation for OpCT-001 for the treatment of primary photoreceptor diseases
27 February 2025 - First iPSC-derived investigational cell therapy, OpCT-001, to be clinically tested for treating primary photoreceptor diseases. ...
Posted by Michael Wonder on 23 Feb 2025
Luxa Biotechnology announces FDA regenerative medicine advanced therapy designation granted to RPESC-RPE-4W transplantation for the treatment of dry age-related macular degeneration
19 February 2025 - Luxa Biotechnology today announced that the US FDA has granted regenerative medicine advanced therapy designation to RPESC-RPE-4W ...
Posted by Michael Wonder on 21 Feb 2025
Green light for groundbreaking personalised cancer therapy that reprogrammes immune system
20 February 2025 - Final guidance published today recommends lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) as an option for treating ...
Posted by Michael Wonder on 13 Feb 2025
NKGen Biotech receives US FDA fast track designation for troculeucel for the treatment of moderate Alzheimer’s disease
12 February 2025 - NKGen Biotech today announced that the US FDA has granted fast track designation for the investigation of ...
Posted 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. ...