Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2022
SQZ Biotechnologies receives FDA fast track designation for its lead cell therapy candidate for the treatment of HPV16 positive tumours
27 April 2022 - Designation Creates Potential to Bring Important New Therapy to Patients Earlier. ...
Posted by Michael Wonder on 27 Apr 2022
Editas Medicine receives FDA rare paediatric disease designation for EDIT-301 for the treatment of beta thalassaemia
26 April 2022 - Editas Medicine today announced that the U.S. FDA granted rare paediatric disease designation to EDIT-301, an investigational, ...
Posted by Michael Wonder on 26 Apr 2022
VBL Therapeutics receives FDA fast track designation for ofra-vec for the treatment of platinum-resistant ovarian cancer
26 April 2022 - OVAL Phase 3 top-line progression-free survival primary outcome data for ofra-vec expected in 2H 2022; with ...
Posted by Michael Wonder on 25 Apr 2022
FDA grants regenerative medicine advanced therapy designation to Autolus’ CAR T cell therapy, obe-cel, for the treatment of adult B-ALL
25 April 2022 - Autolus Therapeutics today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation to its ...
Posted by Michael Wonder on 20 Apr 2022
FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel for prevention of multiple life-threatening infections from six viruses in allogeneic haematopoietic cell transplant patients
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies. ...
Posted 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 ...