Blog
RSS FeedPosted 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. ...
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 ...