Innovent receives fast track designation from the US FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer

12 June 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its TOPO1i anti-CLDN18.2 ADC ...

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FDA grants fast track designation to GCBP and Novel Pharma's GC1130A

10 June 2024 - GC Biopharma and Novel Pharma have announced that the US FDA has granted fast track designation ...

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SpliSense receives FDA fast track designation for SPL84 for the treatment of cystic fibrosis

29 May 2024 - SpliSense today announced that the US FDA has granted fast track designation to SPL84 for cystic ...

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Adicet Bio receives FDA fast track designation for ADI-001 in lupus nephritis

5 June 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the potential ...

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Quince Therapeutics receives US FDA fast track designation for EryDex system

3 June 2024 - Quince Therapeutics today announced that the US FDA has granted fast track designation for its EryDex System ...

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Repare Therapeutics announces fast track designation granted by the FDA for lunresertib in combination with camonsertib for the treatment of platinum resistant ovarian cancer

4 June 2024 - Repare Therapeutics today announced the US FDA has granted fast track designation to lunresertib in combination with ...

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NH TherAguix receives FDA fast track designation for AGuIX, its novel radio-enhancer in the treatment of malignant gliomas, and provides an update on its developments and prospects

30 May 2024 - Key regulatory milestone confirming the interest of the US authorities in AGuIX, a next generation nanodrug ...

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Affimed receives fast track designation for combination therapy of AFM24 with atezolizumab for EGFR wild type non-small cell lung cancer

29 May 2024 - The FDA’s fast track designation was granted after its review of the initial efficacy data of the ...

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Vasomune Therapeutics receives US FDA fast track designation for novel investigational medicine AV-001

28 May 2024 - Vasomune Therapeutics has announced today that the US FDA granted fast track designation for AV-001 for the ...

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Sobi receives US FDA fast track designation for emapalumab-lzsg being investigated in macrophage activation syndrome

24 May 2024 - Sobi North America today announced that the US FDA has granted fast track designation to emapalumab-lzsg being ...

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Theriva Biologics announces fast track designation granted by the US FDA for VCN-01 for the treatment of metastatic pancreatic cancer

23 May 2024 - Theriva Biologics today announced that the US FDA has granted fast track designation to lead clinical candidate ...

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Ractigen Therapeutics secures FDA fast track designation for RAG-01, a first in class saRNA therapy

21 May 2024 - Ractigen Therapeutics proudly announces that its flagship program, RAG-01, has been granted fast track designation by ...

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Transposon receives US FDA fast track designation for TPN-101 for progressive supranuclear palsy

21 May 2024 - TPN-101 is the first PSP treatment to reduce NfL and IL-6 levels, key biomarkers of neurodegeneration ...

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Aprinoia Therapeutics announces fast track designation granted by US FDA to APN-1607 (florzolotau) for the diagnosis of progressive supranuclear palsy

20 May 2024 - Aprinoia Therapeutics today announced that on 8 May 2024, the US FDA granted fast track designation to ...

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SN Bioscience receives FDA fast track designation for small cell lung cancer

9 May 2024 - SN Bioscience announced on 7 May that the FDA has granted fast track designation for small cell ...

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