Blog
RSS FeedPosted by Michael Wonder on 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...
Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...
Posted by Michael Wonder on 09 Oct 2021
FDA approves innovative treatment for paediatric patients with congenital athymia
8 October 2021 - Today, the U.S. FDA approved Rethymic for the treatment of paediatric patients with congenital athymia, a rare ...
Posted by Michael Wonder on 02 Oct 2021
FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia
1 October 2021 - Today, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma) for adult patients with ...
Posted by Michael Wonder on 01 Oct 2021
Kite submits supplemental biologics license application to U.S. FDA for earlier use of Yescarta in large B-cell lymphoma
30 September 2021 - Supplemental biologics license application filing based on landmark ZUMA-7 study, the first randomised clinical trial to evaluate ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 30 Jun 2021
Allogene Therapeutics granted FDA fast track designation for ALLO-605, the first TurboCAR T Cell therapy, for the treatment of relapsed/refractory multiple myeloma
30 June 2021 - TurboCAR technology provides selective, programmable cytokine signaling designed to improve function and potency of AlloCAR T cells. ...
Posted by Michael Wonder on 15 Jun 2021
FDA approves StrataGraft for the treatment of adults with thermal burns
15 June 2021 - Today, the U.S. FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact ...
Posted by Michael Wonder on 27 May 2021
U.S. Food and Drug Administration grants BCMA CAR-T cilta-cel priority review for the treatment for relapsed/refractory multiple myeloma
26 May 2021 - Legend Biotech has announced that the U.S. FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 22 Apr 2021
Allogene Therapeutics announces FDA regenerative medicine advanced therapy designation granted to ALLO-715, an AlloCAR T cell therapy in development for relapsed/refractory multiple myeloma
21 April 2021 - Regenerative medicine advanced therapy designation follows proof of concept data from ALLO-715 UNIVERSAL trial in heavily pretreated, ...
Posted by Michael Wonder on 06 Apr 2021
Kite submits supplemental biologics license application to U.S. FDA for Tecartus in adult patients with relapsed or refractory acute lymphoblastic leukaemia
1 April 2021 - If approved, Tecartus would be the first and only CAR T-cell therapy approved for adult patients ...
Posted by Michael Wonder on 18 Mar 2021
Celularity announces fast track designation by the FDA for its natural killer cell therapy CYNK-001 in the treatment of recurrent glioblastoma multiforme
18 March 2021 - Celularity announced that the company has received fast track designation from the U.S. FDA for its non-genetically ...
Posted by Michael Wonder on 06 Mar 2021
U.S. FDA approves Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...
Posted by Michael Wonder on 20 Feb 2021
Immunocore’s tebentafusp granted breakthrough therapy designation for unresectable or metastatic uveal melanoma from FDA
19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...
Posted by Michael Wonder on 14 Feb 2021
Mallinckrodt provides regulatory update on StrataGraft
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...