Blog
RSS FeedPosted by Michael Wonder on 20 Nov 2023
The FDA is at a crossroads on cell and gene therapies
20 November 2023 - Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people ...
Posted by Michael Wonder on 09 Nov 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
9 November 2023 - Application based on results from TRANSCEND CLL 004, the first pivotal multi-centre trial to show clinical benefit ...
Posted by Michael Wonder on 24 Oct 2023
Immatics receives FDA regenerative medicine advanced therapy designation for ACTengine IMA203 TCR-T monotherapy
24 October 2023 - Regulatory activities underway with an initial focus on a registration directed trial in melanoma as step ...
Posted by Michael Wonder on 20 Oct 2023
FDA grants fast track designation to ANPD001, autologous investigational cell therapy for the treatment of Parkinson's disease
19 October 2023 - Aspen Neuroscience today announced that the US FDA has granted fast track designation for ANPD001 for the ...
Posted by Michael Wonder on 19 Oct 2023
BrainStorm Cell Therapeutics to meet with US FDA to discuss development plan for NurOwn as a treatment of ALS
18 October 2023 - Biologics license application to be withdrawn without prejudice. ...
Posted by Michael Wonder on 17 Oct 2023
Diakonos Oncology awarded FDA fast track designation for innovative dendritic cell vaccine for glioblastoma
17 October 2023 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the Company’s unique ...
Posted by Michael Wonder on 16 Oct 2023
Editas Medicine granted FDA regenerative medicine advanced therapy designation for EDIT-301 for the treatment of severe sickle cell disease
16 October 2023 - Editas Medicine today announced that the US FDA granted regenerative medicine advanced therapy designation to EDIT-301, an ...
Posted by Michael Wonder on 10 Oct 2023
ImmPACT Bio granted FDA fast track designation for IMPT-514 for the treatment of both active, refractory lupus nephritis and systemic lupus erythematosus
10 October 2023 - IMPT-514 is the first CD19/CD20 CAR T-cell therapy in development for lupus. ...
Posted by Michael Wonder on 02 Oct 2023
Avenge Bio receives FDA fast track designation for AVB-001, a novel cell therapy leveraging the LOCOcyte immunotherapy platform
2 October 2023 - Regulatory designation includes platinum-resistant, high grade serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube. ...
Posted by Michael Wonder on 26 Sep 2023
Abeona Therapeutics submits biologics license application to US FDA seeking priority review and approval of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa
26 September 2023 - Abeona Therapeutics today announced the Company has submitted a biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 04 Aug 2023
Orchard Therapeutics completes submission of biologics license application for OTL-200 in MLD to US FDA
3 August 2023 - Four MLD patients identified from ~150,000 newborns screened in prospective studies suggests significantly higher incidence than previously ...
Posted by Michael Wonder on 31 Jul 2023
FDA grants fast track designation to IVS-3001, a CAR-T cell therapy in the treatment of renal cell carcinoma
31 July 2023 - Invectys is pleased to announce the US FDA has granted fast track designation to its revolutionary ...
Posted by Michael Wonder on 12 Jul 2023
Biosyngen's first in class cell therapy BRG01 receives FDA fast track designation
12 July 2023 - On July 6, 2023, Biosyngen received an official notification from the US FDA granting fast track ...
Posted 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. ...