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RSS FeedPosted by Michael Wonder on 02 Oct 2020
Mesoblast receives complete response letter from the FDA for biologics license application for steroid-refractory acute graft versus host disease in children
2 October 2020 - Mesoblast announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter ...
Posted by Michael Wonder on 27 Sep 2020
Precision BioSciences receives fast track designation from U.S. FDA for PBCAR269A, an investigational allogeneic CAR-T therapy for relapsed/refractory multiple myeloma
9 September 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to PBCAR269A for the treatment ...
Posted by Michael Wonder on 23 Sep 2020
FDA grants RMAT designation to MultiStem cell therapy for the treatment of acute respiratory distress syndrome
23 September 2020 - ARDS program well positioned for an expedited path to commercialisation with RMAT and fast track designation. ...
Posted by Michael Wonder on 22 Sep 2020
U.S. FDA accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)
22 September 2020 - Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma. ...
Posted by Michael Wonder on 05 Sep 2020
Kite submits supplemental biologics license application to U.S. FDA for Yescarta in relapsed or refractory indolent non-Hodgkin's lymphomas
4 September 2020 - If approved, Yescarta would be the first CAR T therapy for patients with relapsed or refractory ...
Posted by Michael Wonder on 27 Aug 2020
Editas Medicine receives rare paediatric disease designation for EDIT-301 for the treatment of sickle cell disease
24 August 2020 - Editas Medicine today announced that the U.S. FDA has granted rare paediatric disease designation for EDIT-301, an ...
Posted by Michael Wonder on 20 Aug 2020
Precision BioSciences receives fast track disease designation from U.S. FDA for PBCAR0191 investigational allogeneic CAR T-cell therapy
19 August 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to Precision for PBCAR0191, the ...
Posted by Michael Wonder on 10 Aug 2020
Mallinckrodt announces U.S. FDA filing acceptance of biologics license application for StrataGraft regenerative skin tissue for treatment of adults with deep partial-thickness thermal burns
10 August 2020 - StrataGraft skin tissue, if approved, could reduce or eliminate the need for auto-grafting of healthy skin to ...
Posted by Michael Wonder on 29 Jul 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application to FDA for idecabtagene vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma
29 July 2020 - BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient ...
Posted by Michael Wonder on 24 Jul 2020
FDA approves first cell-based gene therapy for adult patients with relapsed or refractory mantle cell lymphoma
24 July 2020 - Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment ...
Posted by Michael Wonder on 11 Jun 2020
Cell and gene therapies: FDA official on COVID-19 impact
10 June 2020 - Speaking at a session on cell and gene therapies at BIO Digital on Monday, a top US ...
Posted by Michael Wonder on 10 Jun 2020
Mallinckrodt completes rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
9 June 2020 - StrataGraft skin tissue is in development as potential new treatment option for patients with deep partial-thickness thermal ...
Posted by Michael Wonder on 04 Jun 2020
TVAX Biomedical receives fast track designation from the FDA for brain cancer
4 June 2020 - TVAX Biomedical announced today receipt of fast track designation from the U.S. FDA for the use of ...
Posted by Michael Wonder on 13 May 2020
Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma
Bristol Myers Squibb and bluebird bio today announced that the companies received a Refusal to File letter from the U.S. ...
Posted by Michael Wonder on 11 May 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA regenerative medicine advanced therapy designation granted to CTX001 for the treatment of severe hemoglobinopathies
11 May 2020 - CTX001 has received orphan drug designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the ...