SNIPR BIOME announces U.S Food and Drug Administration grants fast track designation for SNIPR001 for prevention of bloodstream infections in haematologic cancer patients

25 January 2022 - SNIPR Biome has been granted fast track designation by the U.S. FDA for SNIPR001.  ...

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Senhwa’s pidnarulex receives US FDA fast track designation for the treatment of solid tumours with BRCA1/2, PALB2 and other HR gene mutations

24 January 2022 - Senhwa Biosciences announced today that the US FDA has granted fast track designation for Pidnarulex, a first ...

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Celcuity receives FDA fast track designation for gedatolisib in HR positive, HER2 negative metastatic breast cancer

18 January 2022 - On track to finalise Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter. ...

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Antares Pharma receives FDA fast track designation for ATRS-1902 for adrenal crisis rescue

18 January 2022 - Antares Pharma today announced that the U.S. FDA has granted fast track designation for ATRS-1902 for adrenal ...

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Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastro-oesophageal junction cancers

18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...

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4D Molecular Therapeutics announces FDA fast track designation granted to 4D-125 for the treatment of X-linked retinitis pigmentosa

10 January 2022 - 4D Molecular Therapeutics announced that the U.S. FDA has granted fast track designation for 4D-125 for treatment ...

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Veru announces FDA grant of fast track designation for enobosarm for the treatment of androgen receptor positive, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer

10 January 2022 - Phase 3 ARTEST registration study of enobosarm in patients with androgen receptor positive, oestrogen receptor positive, human ...

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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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