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RSS FeedPosted by Michael Wonder on 17 Jun 2026
RBI granted fast track designation by FDA, validating its direct to brain stem cell therapy for Alzheimer's disease
15 June 2026 - Regeneration Biomedical today announced that the US FDA has granted fast track designation to the company's ...
Posted by Michael Wonder on 11 Jun 2026
Zemcelpro (UM171 cell therapy) licensing and supply agreements announced for Canada
10 June 2026 - ExCellThera today announced exclusive licensing and supply agreements granting Medexus the Canadian commercialization rights for Zemcelpro ...
Posted by Michael Wonder on 10 Jun 2026
Imugene's azer-cel granted FDA fast track designation for CLL/SLL and MZL
9 June 2026 - Imugene is pleased to announce that the US FDA has granted fast track designation to azer-cel ...
Posted by Michael Wonder on 07 May 2026
Repertoire Immune Medicines announces FDA fast track designation for its investigational immune medicine, RPTR-1-201
7 May 2026 - Repertoire Immune Medicines today announced that the US FDA has granted fast track designation to RPTR-1-201 for ...
Posted by Michael Wonder on 05 May 2026
Free multiple myeloma therapy now available
5 May 2026 - Eligible Australians with multiple myeloma will now have access to a new free therapy, Carvykti, in ...
Posted by Michael Wonder on 30 Apr 2026
Expression Therapeutics receives FDA fast track and rare paediatric disease designations for investigational stem cell therapy for haemophilia A
29 April 2026 - Expression Therapeutics today announced that the US FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 25 Apr 2026
Novartis receives positive CHMP opinion for Itvisma for spinal muscular atrophy
24 April 2026 - Novartis today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 02 Apr 2026
A2 Biotherapeutics receives US FDA fast track designation for A2B543, a logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster
1 April 2026 - A2 Biotherapeutics today announced that the US FDA has granted fast track designation for A2B543, an autologous ...
Posted by Michael Wonder on 01 Apr 2026
Orca Bio announces FDA review extension of BLA for Orca-T for the treatment of haematologic malignancies
1 April 2026 - Orca Bio today announced that the US FDA has extended the review timeline of its biologics license ...
Posted by Michael Wonder on 18 Mar 2026
EMA grants PRIME designation to TolerogenixX’s MIC-Lx therapy for donor-specific immune tolerance in kidney transplantation
11 March 2026 - TolerogenixX today announced that the EMA has granted PRIority MEdicines (PRIME) designation to its lead cell ...
Posted by Michael Wonder on 11 Mar 2026
Capricor Therapeutics announces establishment of new PDUFA date for deramiocel BLA
10 March 2026 - Capricor Therapeutics today announced that the US FDA has lifted the previously issued complete response letter ...
Posted 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 ...