Blog
RSS FeedPosted by Michael Wonder on 10 Sep 2024
Cartesian Therapeutics receives FDA rare paediatric disease designation for Descartes-08 for the treatment of juvenile dermatomyositis
9 September 2024 - Cartesian Therapeutics today announced that the US FDA has granted rare paediatric disease designation to Descartes-08 ...
Posted by Michael Wonder on 07 Sep 2024
Axogen completes submission of biologics license application to US FDA for Avance Nerve Graft
6 September 2024 - Axogen announced that it has completed the rolling submission process for its biologics license application to the ...
Posted by Michael Wonder on 25 Aug 2024
Abata Therapeutics receives FDA fast track designation for ABA-101 for the treatment of progressive multiple sclerosis
22 August 2024 - Abata Therapeutics today announced that the US FDA has granted fast track designation for ABA-101 for the ...
Posted by Michael Wonder on 30 Jul 2024
AffyImmune receives FDA regenerative medicine advanced therapy designation for AIC100 in recurrent anaplastic thyroid cancer
23 July 2024 - RMAT designation follows FDA’s review of available preliminary clinical evidence that AIC100 has the potential to address ...
Posted by Michael Wonder on 24 Jul 2024
FDA accepts Mesoblast's biologics license application for Ryoncil in children with steroid-refractory acute graft versus host disease
23 July 2024 - Mesoblast announced that the US FDA has accepted its biologics license application resubmission for Ryoncil (remestemcel-L) ...
Posted by Michael Wonder on 19 Jul 2024
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
17 July 2024 - PDUFA target action date of 15 January 2025. ...
Posted by Michael Wonder on 09 Jul 2024
Adicet Bio receives FDA fast track designation for ADI-270 in metastatic/advanced clear cell renal cell carcinoma
8 July 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-270 for the ...
Posted by Michael Wonder on 09 Jul 2024
Mesoblast resubmits biologics license application with US FDA for approval of Ryoncil in children with steroid-refractory acute graft versus host disease
8 July 2024 - Mesoblast announced today it has resubmitted its BLA for approval of Ryoncil (remestemcel-L) in the treatment ...
Posted by Michael Wonder on 23 Jun 2024
Neurotech Pharmaceuticals receives priority review of biologics license application for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia type 2
20 June 2024 - Priority review granted with a PDUFA goal date set for 17 December 2024. ...
Posted by Michael Wonder on 20 Jun 2024
Aurion Biotech receives breakthrough therapy designation and regenerative medicine advanced therapy designation for its drug candidate AURN001
19 June 2024 - First allogeneic cell therapy to receive both FDA designations for the treatment of corneal oedema secondary to ...
Posted by Michael Wonder on 06 Jun 2024
BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease cell therapy candidate bemdaneprocel
31 May 2024 - Regenerative Medicine Advanced Therapy designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated ...
Posted by Michael Wonder on 05 Jun 2024
TScan Therapeutics receives FDA’s regenerative medicine advanced therapy designation for its two lead TCR-T therapy candidates for the treatment of heme malignancies
29 May 2024 - RMAT designation granted for both TSC-100 and TSC-101 for the treatment of patients with AML, ALL, and ...
Posted by Michael Wonder on 30 May 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as a new CAR T-cell therapy for relapsed or refractory mantle cell lymphoma
30 May 2024 - In the MCL cohort of TRANSCEND-NHL-001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion ...
Posted by Michael Wonder on 23 May 2024
Cartesian Therapeutics receives FDA regenerative medicine advanced therapy designation for Descartes-08 for the treatment of myasthenia gravis
22 May 2024 - Cartesian Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation for ...
Posted by Michael Wonder on 22 May 2024
Atara Biotherapeutics submits tabalecleucel (tab-cel) biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease with US FDA
20 May 2024 - First allogeneic T-cell therapy BLA submission to US FDA. ...