Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2022
Precigen receives fast track designation for PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukaemia
4 April 2022 - PRGN-3006 UltraCAR-T previously received orphan drug designation in patients with acute myeloid leukaemia by the US FDA. ...
Posted by Michael Wonder on 01 Apr 2022
FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma
1 April 2022 - Today, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma) for adult patients with ...
Posted by Michael Wonder on 23 Mar 2022
StemCyte has submitted its application for a biologics license for its allogeneic umbilical cord haematopoietic progenitor cell product "HPC-Cord Blood", to the US FDA
22 March 2022 - The BLA has been accepted for quality review and StemCyte anticipates licensure in 2023 ...
Posted by Michael Wonder on 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
Posted by Michael Wonder on 03 Mar 2022
U.S. Food and Drug Administration grants Cabaletta Bio fast track designation for MuSK-CAART
1 March 2022 - Fast Track Designation granted to improve activities of daily living and muscle strength in patients with ...
Posted by Michael Wonder on 01 Mar 2022
Carvykti (ciltacabtagene autoleucel), BCMA directed CAR-T therapy, receives U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma
28 February 2022 - Approval is primarily based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 17 Feb 2022
U.S. FDA accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022. ...
Posted by Michael Wonder on 10 Feb 2022
Gamida Cell initiates rolling submission of biologics license application for omidubicel
9 February 2022 - Gamida Cell today announced that it has initiated the biologics license application rolling submission process with the ...
Posted by Michael Wonder on 01 Feb 2022
U.S. FDA approves new label update for CAR T-cell therapy Yescarta showing prophylactic steroid use improves management of cytokine release syndrome
31 January 2022 - Updated toxicity management strategy can improve certain adverse events without compromising the activity of Yescarta. ...
Posted by Michael Wonder on 18 Jan 2022
Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastro-oesophageal junction cancers
18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...
Posted by Michael Wonder on 13 Jan 2022
CBMG receives FDA regenerative medicine advanced therapy and fast track designations for bi-Specific anti-CD19/CD20 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma
12 January 2022 - Cellular Biomedicine Group today announced that the FDA granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting ...
Posted by Michael Wonder on 11 Jan 2022
CARsgen announces CT041 CAR T-cell product candidate granted RMAT designation by the FDA
10 January 2022 - CARsgen Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CT041 for ...
Posted by Michael Wonder on 27 Dec 2021
Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-001 in development for the treatment of AML
27 December 2021 - Celularity today announced the U.S. FDA has granted fast track designation for its non-genetically modified cryopreserved human ...
Posted by Michael Wonder on 26 Dec 2021
Lion TCR receives FDA fast track designation for its HBV specific TCR T cell therapy for hepatocellular carcinoma
23 December 2021 - Lion TCR today announced that it has received fast track designation from U.S. FDA for LioCyx-M004, autologous ...
Posted by Michael Wonder on 29 Nov 2021
U.S. Food and Drug Administration approves Longeveron’s Lomecel-B for rare paediatric disease designation to treat life-threatening infant heart condition
18 November 2021 - Phase 2 clinical trial underway for hypoplastic left heart syndrome, which affects approximately 1,000 babies per ...