COUR Pharmaceuticals receives FDA fast track designation for CNP-104 for the treatment of primary biliary cholangitis

10 January 2021 - COUR Pharmaceuticals today announced the U.S. FDA granted fast track designation to the Company's investigational therapy CNP-104 ...

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Dynacure receives fast track designation for DYN101, an investigational antisense oligonucleotide for the treatment of myotubular and centronuclear myopathies

6 January 2022 - Dynacure today announced that the U.S. FDA has granted fast track designation for its lead product ...

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Genprex receives U.S. FDA fast track designation for Reqorsa immunogene therapy in combination with Keytruda for the treatment of non-small-cell lung cancer

3 January 2022 - Second FDA fast track designation further validates the potential of Reqorsa. ...

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FDA grants ILiAD Biotechnologies fast track designation for next generation pertussis vaccine BPZE1

3 January 2021 - ILiAD Biotechnologies, today announced that the U.S. FDA has granted fast track designation to BPZE1, a next ...

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Vivoryon Therapeutics receives FDA fast track designation for varoglutamstat in early Alzheimer’s disease

22 December 2021 - 21 – Vivoryon Therapeutics today announced that the U.S. FDA has granted fast track designation for varoglutamstat ...

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Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-001 in development for the treatment of AML

27 December 2021 - Celularity today announced the U.S. FDA has granted fast track designation for its non-genetically modified cryopreserved human ...

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Lion TCR receives FDA fast track designation for its HBV specific TCR T cell therapy for hepatocellular carcinoma

23 December 2021 - Lion TCR today announced that it has received fast track designation from U.S. FDA for LioCyx-M004, autologous ...

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Investigational Alzheimer’s disease therapy lecanemab granted FDA fast track designation

23 December 2021 - Eisai and Biogen announced today that lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of ...

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Xalud Therapeutics receives FDA fast track designation for XT-150 for the treatment of pain associated with osteoarthritis of the knee

17 December 2021 - Xalud Therapeutics announced today that the United States FDA has granted fast track designation to the Company’s ...

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Sapience Therapeutics receives FDA fast track designation for ST101 for advanced cutaneous melanoma

15 December 2021 - Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead program, ...

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Nuvation Bio receives FDA fast track designation for NUV-422 for the treatment of high grade gliomas, including glioblastoma multiforme

15 December 2021 - Nuvation Bio today announced that the U.S. FDA has granted fast track designation to NUV-422, a cyclin-dependent ...

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Sapience Therapeutics receives FDA fast track designation for ST101 for the treatment of recurrent glioblastoma multiforme

6 December 2021 -  Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead ...

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U.S. FDA grants Bionomics fast track designation to BNC210 for the acute treatment of social anxiety disorder and other anxiety related disorders

1 December 2021 -  Bionomics is pleased to announce that the U.S. FDA has granted fast track designation to the ...

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Hepion Pharmaceuticals receives FDA fast track designation for CRV431 for the treatment of NASH

30 November 2021 - Hepion Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for the Company’s lead ...

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Isofol Medical receives FDA fast track designation for arfolitixorin in advanced colorectal cancer

23 November 2021 - Isofol Medical announced today that the U.S. FDA has granted fast track designation for the development ...

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