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RSS FeedPosted by Michael Wonder on 04 May 2023
Humacyte’s human acellular vessel receives FDA’s regenerative medicine advanced therapy designation for urgent arterial repair following vascular trauma
4 May 2023 - HAV granted second RMAT designation by the FDA. ...
Posted by Michael Wonder on 17 Apr 2023
Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
Posted by Michael Wonder on 17 Apr 2023
FDA approves cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation
17 April 2023 - Today, the US FDA approved Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy to quicken ...
Posted by Michael Wonder on 12 Apr 2023
Kala Pharmaceuticals receives FDA fast track designation for KPI-012, a human MSC-S therapy for persistent corneal epithelial defect
12 April 2023 - Kala Pharmaceuticals today announced that the US FDA has granted fast track designation for Kala’s human mesenchymal ...
Posted by Michael Wonder on 05 Apr 2023
Caribou Biosciences announces FDA granted fast track designation to CB-011, an allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma
4 April 2023 - CaMMouflage Phase 1 trial for CB-011 enrolling patients with relapsed or refractory multiple myeloma at dose level ...
Posted by Michael Wonder on 27 Mar 2023
Iovance Biotherapeutics completes biologics license application submission for lifileucel in advanced melanoma
24 March 2023 - First TIL therapy BLA submission to US FDA. ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts Mesoblast’s resubmission of the biologic license application for remestemcel-L in children with steroid-refractory acute graft versus host disease as a complete response
7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...
Posted 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. ...