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RSS FeedPosted by Michael Wonder on 16 Apr 2025
FDA grants fast track status to Prescient’s PTX-100, advancing commercialisation pathway
16 April 2025 - Prescient Therapeutics has received fast track designation from the US FDA for its lead candidate PTX-100, ...
Posted by Michael Wonder on 15 Apr 2025
Precision BioSciences receives US FDA fast track designation for PBGENE-HBV, a first in class gene editing therapy designed to eliminate the root cause of chronic hepatitis B
15 April 2025 - Precision BioSciences today announced that the US FDA has granted fast track designation for PBGENE-HBV, the Company’s ...
Posted by Michael Wonder on 14 Apr 2025
SynOx Therapeutics receives fast track designation from US FDA for emactuzumab for tenosynovial giant cell tumours
14 April 2025 - SynOx Therapeutics today announced that the US FDA has granted fast track designation to emactuzumab for the ...
Posted by Michael Wonder on 11 Apr 2025
Verve Therapeutics receives US FDA fast track designation for VERVE-102, an in vivo base editing medicine targeting PCSK9
11 April 2025 - Verve Therapeutics today announced that the US FDA has granted fast track designation for VERVE-102 for ...
Posted by Michael Wonder on 10 Apr 2025
Arcturus Therapeutics receives US FDA fast track designation for the STARR mRNA vaccine candidate ARCT-2304 for pandemic influenza A virus H5N1
10 April 2025 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation for the self-amplifying mRNA ...
Posted by Michael Wonder on 08 Apr 2025
Allogene granted three US FDA fast track designations for ALLO-329, a next generation dual targeted CD19/CD70 allogeneic CAR T for the treatment of lupus, myositis and scleroderma
7 April 2025 - Phase 1 RESOLUTION trial initiation planned for mid-2025 with initial proof of concept by year end ...
Posted by Michael Wonder on 02 Apr 2025
Biogen’s investigational tau-targeting therapy BIIB080 receives FDA fast track designation for the treatment of Alzheimer’s disease
2 April 2025 - Biogen today announced that the US FDA has granted fast track designation to BIIB080, an investigational ...
Posted by Michael Wonder on 27 Mar 2025
Chlamydia vaccine candidate granted fast track designation by the US FDA
26 March 2025 - The US FDA has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of ...
Posted 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. ...