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RSS FeedPosted by Michael Wonder on 14 Feb 2023
Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
13 February 2023 - A top official from the US FDA said he wants to see something similar to the agency’s ...
Posted by Michael Wonder on 13 Feb 2023
IASO Bio announces CT103A granted regenerative medicine advanced therapy and fast track designations by the FDA
12 February 2023 - IASO Biotherapeutics today announced that the US FDA has granted both regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 09 Feb 2023
FDA grants regenerative medicine advanced therapy designation for rexlemestrocel-L in chronic low back oain
9 February 2023 - Mesoblast today announced that the US FDA's Office of Tissues and Advanced Therapies has granted regenerative ...
Posted by Michael Wonder on 01 Feb 2023
Artiva Biotherapeutics receives FDA fast track designation for AB-101
31 January 2023 - Granted fast track designation by US FDA for the treatment of relapsed/refractory non-Hodgkin lymphoma of B cell ...
Posted by Michael Wonder on 26 Jan 2023
DiscGenics announces FDA regenerative medicine advanced therapy designation granted to IDCT for degenerative disc disease
26 January 2023 - DiscGenics today announced the US FDA granted regenerative medicine advanced therapy designation to injectable disc cell ...
Posted by Michael Wonder on 24 Dec 2022
Adaptimmune announces initiation of biologics license application submission for afami-cel, its first generation engineered TCR T-cell therapy targeting MAGE-A4, for the treatment of synovial sarcoma
23 December 2022 - Afami-cel has the potential to be the first approved engineered TCR T-cell therapy for a solid tumour. ...
Posted by Michael Wonder on 06 Dec 2022
SQZ Biotechnologies receives FDA fast track designation for its eAPC therapeutic candidate for treatment of HPV16 positive tumours
6 December 2022 - Stable disease observed in two out of four evaluable patients in eAPC Phase 1/2 trial including a ...
Posted by Michael Wonder on 29 Nov 2022
Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy
29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...
Posted by Michael Wonder on 05 Nov 2022
FDA finalises umbrella trial guidance for cell and gene therapies
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...
Posted by Michael Wonder on 27 Oct 2022
Myeloid Therapeutics announces FDA fast track designation for MT-101 for the treatment of CD5 positive relapsed/refractory PTCL
27 October 2022 - MT-101 is the first mRNA engineered CAR monocyte therapy to be dosed in humans. ...
Posted by Michael Wonder on 28 Sep 2022
CRISPR Therapeutics announces FDA regenerative medicine advanced therapy designation granted to CTX130 for the treatment of cutaneous T-cell lymphomas
28 September 2022 - CRISPR Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CTX130, ...
Posted by Michael Wonder on 31 Aug 2022
US FDA grants fast track designation for Longeveron’s Lomecel-B product for treatment of hypoplastic left heart syndrome in infants
31 August 2022 - New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting ...
Posted by Michael Wonder on 25 Aug 2022
Iovance Biotherapeutics initiates biologics license application submission for lifileucel in advanced melanoma
25 August 2022 - First TIL therapy BLA submission initiated with U.S. FDA. ...
Posted by Michael Wonder on 17 Aug 2022
bluebird bio announces U.S. commercial infrastructure to enable patient access to Zynteglo, the first and only FDA approved gene therapy for people with beta thalassaemia who require regular red blood cell transfusions
17 August 2022 - Innovative outcomes-based contract offering includes single upfront payment and up to 80% risk-sharing. ...
Posted by Michael Wonder on 17 Aug 2022
FDA approves first cell based gene therapy to treat adult and paediatric patients with beta thalassaemia who require regular blood transfusions
17 August 2022 - Today, the US FDA approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of ...