Blog
RSS FeedPosted by Michael Wonder on 21 Mar 2025
Secretome Therapeutics granted FDA fast track designation for STM-01, a neonatal cardiac progenitor cell therapy for HFpEF
20 March 2025 - Secretome Therapeutics today announced that the US FDA has granted fast track designation to STM-01, the company’s ...
Posted by Michael Wonder on 20 Mar 2025
Azercabtagene zapreleucel granted FDA fast track designation in blood cancer DLBCL
19 March 2025 - Imugene is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 19 Mar 2025
Nipocalimab, the first and only investigational treatment to be granted US FDA breakthrough therapy designation for the treatment of adults with moderate to severe Sjögren’s disease, has now received fast track designation
18 March 2025 - This marks the fourth nipocalimab FDA fast track designation. ...
Posted by Michael Wonder on 18 Mar 2025
Cellphire Therapeutics CLPH-511 fast track designation granted
17 March 2025 - Cellphire Therapeutics today announced that the US FDA has granted fast track designation for CLPH-511 (frozen activated ...
Posted by Michael Wonder on 12 Mar 2025
Atsena Therapeutics granted US FDA fast track designation for ATSN-201 gene therapy to treat X-linked retinoschisis
12 March 2025 - Marks third FDA designation for ATSN-201, which has also received rare paediatric disease designation and orphan drug ...
Posted by Michael Wonder on 03 Mar 2025
Latigo Biotherapeutics granted FDA fast track designation for LTG-001, potential best in class Nav1.8 inhibitor for the non-opioid treatment of acute pain
3 March 2025 - LTG-001 demonstrated favourable safety and tolerability profile with predictable pharmacokinetics in Phase 1 trial. ...
Posted by Michael Wonder on 03 Mar 2025
Avobis Bio receives FDA fast track designation for AVB-114 implantable cell therapy for Crohn's perianal fistulas
27 February 2025 - Only implantable cell therapy for Crohn's perianal fistulas with FDA IND clearance and fast track designation. ...
Posted by Michael Wonder on 27 Feb 2025
BlueRock Therapeutics receives FDA fast track designation for OpCT-001 for the treatment of primary photoreceptor diseases
27 February 2025 - First iPSC-derived investigational cell therapy, OpCT-001, to be clinically tested for treating primary photoreceptor diseases. ...
Posted by Michael Wonder on 26 Feb 2025
Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer
26 February 2025 - Pyxis Oncology today announced that the US FDA has granted fast track designation to PYX-201 for the ...
Posted by Michael Wonder on 24 Feb 2025
US FDA grants fast track designation to Coherent Biopharma’s CBP-1019
21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...
Posted by Michael Wonder on 24 Feb 2025
Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia
24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...
Posted by Michael Wonder on 20 Feb 2025
World’s first potential target therapy for diffuse gastric cancer granted fast track designation by the US FDA
20 February 2025 - Signet Therapeutics announced that the US FDA has granted fast track designation for SIGX1094, the world's first ...
Posted by Michael Wonder on 20 Feb 2025
Doron Therapeutics receives FDA regenerative medicine advanced therapy designation for Motys for treatment of symptoms associated with osteoarthritis
19 February 2025 - Doron Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 20 Feb 2025
Fast track granted by FDA for NNZ-2591 in Pitt Hopkins syndrome
19 February 2025 - : Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 ...
Posted by Michael Wonder on 18 Feb 2025
Rznomics liver cancer drug candidate secures fast track designation
17 February 2025 - Second fast track designation following brain cancer approval. ...