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RSS FeedPosted by Michael Wonder on 08 Feb 2026
FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma
6 February 2026 - FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. ...
Posted by Michael Wonder on 21 Jan 2026
US FDA grants to Wugen’s WU-CART-007 breakthrough therapy designation for treatment of relapsed or refractory T cell acute lymphoblastic leukaemia / T cell lymphoblastic lymphoma
21 January 2026 - Wugen today announced that it has received breakthrough therapy designation from the US FDA for its ...
Posted by Michael Wonder on 20 Jan 2026
FDA grants regenerative medicine advanced therapy designation to iRegene's NouvNeu001, making it the world's first iPSC therapy with both FTD and RMAT recognitions
19 January 2026 - iRegene Therapeutics today announced that its lead product, NouvNeu001, has been granted regenerative medicine advanced therapy ...
Posted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 05 Jan 2026
Protara Therapeutics receives both FDA breakthrough therapy and fast track designations for TARA-002 in paediatric patients with lymphatic malformations
5 January 2026 - Protara Therapeutics today announced that the US FDA has granted both breakthrough therapy and fast track designations ...
Posted by Michael Wonder on 10 Dec 2025
Senti Bio receives FDA regenerative medicine advanced therapy designation for SENTI-202 in the treatment of adults with relapsed or refractory acute myeloid leukaemia
9 December 2025 - Senti Biosciences today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 07 Dec 2025
FDA approves Omisirge as first approved cell therapy to treat severe aplastic anaemia
5 December 2025 - Ayrmid announces that it has received US FDA approval for Omisirge (Omidubicel-onlv) for the treatment of ...
Posted by Michael Wonder on 04 Dec 2025
FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma
4 December 2025 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, a BMS Company) for adults with relapsed ...
Posted by Michael Wonder on 22 Oct 2025
Immusoft receives FDA fast track designation for ISP-001, a first in class engineered B-cell therapy for MPS I
21 October 2025 - Prospectively designed for scalability and re-dosability, Immusoft's engineered B cells represent the next generation of advanced ...
Posted by Michael Wonder on 11 Oct 2025
FDA frants RMAT designation to Avobis Bio's implantable cell therapy AVB-114 for Crohn's perianal fistulas
3 October 2025 - Avobis Bio announced today that the US FDA has granted regenerative medicine advanced therapy designation for AVB-114, ...
Posted by Michael Wonder on 07 Oct 2025
Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies
6 October 2025 - FDA assigns PDUFA target action date of 6 April 2026. ...
Posted by Michael Wonder on 30 Sep 2025
Umoja Biopharma announces that UB-VV111 receives FDA fast track designation for relapsed/refractory B-cell malignancies
30 September 2025 - Umoja Biopharma announced today that the US FDA has granted fast track designation to UB-VV111 for the ...
Posted by Michael Wonder on 05 Sep 2025
CERo Therapeutics receives FDA fast track designation for CER-1236 in acute myeloid leukaemia
5 September 2025 - CERo Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 13 Aug 2025
Creative Medical Technology secures FDA fast track designation for CELZ-201-DDT - advancing breakthrough therapy for chronic lower back pain
13 August 2025 - Creative Medical Technology Holdings today announced that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 04 Aug 2025
Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma
4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application ...