Tempest granted fast track designation from the US FDA for amezalpat to treat patients with hepatocellular carcinoma

10 January 2025 - Tempest Therapeutics today announced that the US FDA has granted fast track designation to amezalpat (TPST-1120), an ...

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Bracco Imaging receives FDA fast track designation for BR55, ultrasound molecular imaging agent for the detection of active bowel inflammation in Crohn's disease

6 February 2025 - BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the ...

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Adicet Bio receives FDA fast track designation for ADI-001 for the treatment of refractory systemic lupus erythematosus with extra-renal involvement

5 February 2025 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the ...

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FDA grants Vicore’s buloxibutid fast track designation for idiopathic pulmonary fibrosis

29 January 2025 -  Vicore Pharma today announced that the US FDA has granted fast track designation to its lead ...

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Clarity receives US FDA fast track designation for Cu 64 SAR-bisPSMA in biochemical recurrence of prostate cancer

24 January 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...

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Nacuity Pharmaceuticals granted US FDA fast track designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa

21 January 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted fast track designation to NPI-001 (N-acetylcysteine amide) ...

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Dyne Therapeutics receives FDA fast track designation for DYNE-101 for the treatment of myotonic dystrophy type 1

21 January 2025 - Dyne Therapeutics today announced that the US FDA has granted fast track designation for DYNE-101 for ...

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Solid Biosciences receives FDA fast track designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia

21 January 2025 - Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and ...

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Life Molecular Imaging secures FDA fast track designation for [18F] florbetaben in diagnosing cardiac AL and ATTR amyloidosis

21 January 2025 - [18F] florbetaben has been granted a fast track designation for cardiac amyloidosis, which will expedite the development ...

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Lokon Pharma receives FDA fast track designation for LOAd703 for the treatment of pancreatic cancer

10 January 2025 - Lokon Pharma today announced that the US FDA has granted fast track designation for the company´s product ...

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FDA grants fast track designation to Spinogenix's SPG601 for treatment of Fragile X syndrome, a common inherited form of autism

13 January 2025 - -- Spinogenix today announced that the US FDA has granted fast track designation to SPG601 for the ...

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BridgeBio Oncology Therapeutics granted US FDA fast track designation for BBO-8520 for KRASG12C mutated metastatic non-small cell lung cancer

9 January 2025 - The US FDA has granted fast track designation to BBO-8520 for the treatment of adult patients with ...

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Mersana Therapeutics announces additional FDA fast track designation granted to emiltatug ledadotin (XMT-1660)

10 January 2025 - Mersana Therapeutics today announced the US FDA recently granted an additional fast track designation to XMT-1660. ...

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PureTech receives FDA fast track designation for LYT-200 in acute myeloid leukaemia

9 January 2024 - Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of ...

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Marengo’s first in class invikafusp alfa (STAR0602) receives US FDA fast track designation for treatment of unresectable, locally advanced, or metastatic colorectal cancers with high tumour mutational burden

8 January 2025 - Initial safety and efficacy data from Phase 1 STARt-001 trial showed promising single agent clinical activity ...

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