Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 21 May 2024
Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews
20 May 2024 - Researchers to present new Phase 2 data showing safety and anti-leukaemic activity with WU-CART-007 and additional new ...
Posted by Michael Wonder on 16 May 2024
Axogen initiates rolling submission of biologics license application to US FDA for Avance Nerve Graft
16 May 2024 - Axogen is pleased to announce that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 15 May 2024
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
Posted by Michael Wonder on 23 Apr 2024
Abeona Therapeutics provides regulatory update on Pz-cel
22 April 2024 - Abeona Therapeutics today announced a regulatory update for prademagene zamikeracel (pz-cel). ...
Posted by Michael Wonder on 08 Apr 2024
Carvykti is the first and only BCMA targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
Posted by Michael Wonder on 05 Apr 2024
US FDA approves Bristol Myers Squibb and 2seventy bio’s Abecma for triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy
5 April 2024 - Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% ...
Posted by Michael Wonder on 19 Mar 2024
Deverra Therapeutics granted FDA regenerative medicine advanced therapy and orphan drug designations for DVX101 (Dilanubicel) for the treatment of acute myeloid leukaemia
19 March 2024 - Deverra Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to its lead ...
Posted by Michael Wonder on 15 Mar 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
14 March 2024 - In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in ...