Blog
RSS FeedPosted by Michael Wonder on 10 Jul 2023
MyoPax receives rare paediatric disease designation from FDA for breakthrough regenerative cell product in exstrophy-epispadias complex
10 July 2023 - The US FDA granted a rare paediatric Disease designation to MyoPax.. ...
Posted by Michael Wonder on 06 Jul 2023
IPS Heart receives US FDA rare paediatric drug designation for ISX9-CPC stem cell therapy for treatment of cardiomyopathy associated with Danon disease
6 July 2023 - Marks third rare paediatric drug designation granted by FDA for pipeline candidate. ...
Posted by Michael Wonder on 29 Jun 2023
FDA approves first cellular therapy to treat patients with type 1 diabetes
28 June 2023 - Today, the US FDA approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased ...
Posted by Michael Wonder on 20 Jun 2023
Precigen receives breakthrough therapy designation for PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis
20 June 2023 - Designation based on positive Phase 1 clinical data that showed 50% of patients were "surgery-free" (Complete ...
Posted by Michael Wonder on 07 Jun 2023
Legend Biotech announces submission of supplemental application to the US FDA for expanded use of Carvykti (ciltacabtagene autoleucel)
6 June 2023 - The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint ...
Posted by Michael Wonder on 02 Jun 2023
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in lupus nephritis
1 June 2023 - KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor T-cell therapy designed to deplete B cells, ...
Posted by Michael Wonder on 27 May 2023
Iovance Biotherapeutics announces US FDA acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma
26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...
Posted by Michael Wonder on 15 May 2023
ImmPACT Bio granted FDA fast track designation for IMPT-314 in patients with relapsed or refractory aggressive B-cell lymphoma
15 May 2023 - Bispecific CD19/CD20 CAR T therapy demonstrated unmatched safety and durability in UCLA-led Phase 1 study. ...
Posted 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 ...