Blog
RSS FeedPosted by Michael Wonder on 25 Oct 2018
FDA's Gottlieb 'extremely worried' on CAR-T reimbursement
24 October 2018 - FDA Commissioner Scott Gottlieb stressed the need for reform on the reimbursement side of medicine, calling it ...
Posted by Michael Wonder on 24 Sep 2018
Avita Medical announces FDA approval of the Recell system for the treatment of severe burns in the U.S
21 September 2018 - Point-of-care regenerative medicine technology approved to treat second and third-degree burns using Spray-On Skin Cells product. ...
Posted by Michael Wonder on 07 Aug 2018
Nohla Therapeutics receives FDA fast track designation for dilanubicel for allogeneic cord blood transplant patients
6 August 2018 - Nohla Therapeutics today announced that the U.S. FDA has granted fast track designation to dilanubicel (NLA101) for ...
Posted by Michael Wonder on 09 Jul 2018
Enzyvant announces initiation of RVT-802 rolling BLA submission for the treatment of complete DiGeorge anomaly
9 July 2018 - Completion of rolling BLA submission anticipated by end of 2018. ...
Posted by Michael Wonder on 03 Jul 2018
Cellerant Therapeutics announces FDA grants regenerative medicine advanced therapy designation for romyelocel-L to prevent infections during neutropenia
2 July 2018 - RMAT designation confers similar advantages as breakthrough therapy designation. ...
Posted by Michael Wonder on 20 Jun 2018
Caladrius receives FDA regenerative medicine advanced therapy designation for CD34+ cell therapy for treating refractory angina
19 June 2018 - Caladrius Biosciences announces today that the U.S. FDA has granted regenerative medicine advanced therapy designation to the ...
Posted by Michael Wonder on 05 May 2018
Novartis matches Gilead on price in new CAR-T use
3 May 2018 - Novartis’ CAR-T therapy Kymriah will be available in the US to adults with relapsed large B-cell ...
Posted by Michael Wonder on 01 May 2018
Kymriah (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma
1 May 2018 - Kymriah is the only CAR-T therapy FDA-approved for two distinct indications - in non-Hodgkin lymphoma (NHL) and ...
Posted by Michael Wonder on 13 Mar 2018
AmnioFix injectable granted regenerative medicine advanced therapy designation by the FDA for the treatment of osteoarthritis of the knee
9 March 2018 - MiMedx Group today announced that the U.S. FDA has granted MiMedx's micronized amniotic tissue, AmnioFix Injectable, ...
Posted by Michael Wonder on 08 Mar 2018
Balancing safety and innovation for cell-based regenerative medicine
8 March 2018 - Regenerative medicine is a field that involves replacing, engineering, or regenerating human cells, tissues, or organs to ...
Posted by Michael Wonder on 30 Jan 2018
Abeona receives FDA regenerative medicine advanced therapy designation for EB-101 gene therapy in epidermolysis bullosa
29 January 2018 - First gene therapy RMAT designation for epidermolysis bullosa. ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 22 Dec 2017
Mesoblast receives FDA regenerative medicine advanced therapy designation for its cell therapy in heart failure patients with left ventricular assist devices
21 December 2017 - Mesoblast today announced that the United States FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...
Posted by Michael Wonder on 14 Dec 2017
Months after approval, breakthrough cancer drug given to just five patients
14 December 2017 - No Medicare coverage, one-by-one rulings by private insurers. ...
Posted by Michael Wonder on 22 Nov 2017
The promise and challenges of CAR-T gene therapy
22 November 2017 - The recent approvals of 2 one-time gene therapies for refractory paediatric acute lymphoblastic leukaemia and adult relapsed ...