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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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. ...

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