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RSS FeedPosted 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 ...
Posted by Michael Wonder on 30 Jul 2025
Calidi Biotherapeutics receives FDA fast track designation for CLD-201 (SuperNova), a first in class stem cell loaded viral therapy for the treatment of patients with soft tissue sarcoma
29 July 2025 - Calidi Biotherapeutics today announced that it received fast track designation from the US FDA for CLD-201 (SuperNova), ...
Posted by Michael Wonder on 18 Jul 2025
Pierre Fabre announces transfer of investigational new drug application for tabelecleucel from Atara Biotherapeutics
15 July 2025 - Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program. ...
Posted by Michael Wonder on 15 Jul 2025
Atara Biotherapeutics provides regulatory and business updates on tabelecleucel
14 July 2025 - Atara Biotherapeutics resubmits tabelecleucel biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease to ...
Posted by Michael Wonder on 11 Jul 2025
Capricor Therapeutics provides regulatory update on deramiocel BLA for Duchenne muscular systrophy
11 July 2025 - Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in ...
Posted by Michael Wonder on 30 Jun 2025
Minovia Therapeutics announces FDA fast track and rare paediatric disease designations for MNV-201 in Pearson syndrome
30 June 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 16 May 2025
FDA grants regenerative medicine advanced therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
15 May 2025 - BrainChild Bio advancing BCB-276 towards BLA submission with a single pivotal Phase 2 trial planned to ...
Posted by Michael Wonder on 14 May 2025
FDA fast tracks therapy for radiation-induced dry mouth
7 May 2025 - A therapy under development at the University of Wisconsin School of Medicine and Public Health to ...
Posted by Michael Wonder on 22 Apr 2025
FDA grants breakthrough therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
22 April 2025 - Breakthrough therapy designation is based on the encouraging survival data from the Phase 1 BrainChild-03 trial in ...