Korean drug for metabolism-related steatohepatitis gets FDA’s fast track designation

28 March 2024 - D&D Pharmatech said Thursday that DD01, an injectable treatment for metabolic-associated steatohepatitis (MASH) being developed by ...

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Johnson & Johnson's nipocalimab granted US FDA fast track designation to reduce the risk of foetal neonatal allo-immune thrombocytopenia in allo-immunised pregnant adults

26 March 2024 - The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported ...

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ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment

15 March 2024 - ImmVira has recently announced that the US FDA has granted fast track designation for oncolytic virus product ...

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Keros Therapeutics announces US FDA fast track designation for KER-050 in lower-risk myelodysplastic syndromes

14 March 2024 - Keros Therapeutics today announced that the US FDA has granted fast track designation for KER-050 (elritercept) for ...

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Trellis Bioscience's TRL1068 receives FDA fast track and QIDP designations, amplifying commitment to combat infectious diseases

6 March 2024 - Trellis Bioscience is thrilled to announce that its lead antibody candidate, TRL1068, has been granted fast ...

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Ellipses' next generation selective RET inhibitor EP0031/A400 granted fast track designation by US FDA

5 March 2024 - Ellipses Pharma announced today that it has received fast track designation from the US FDA for its ...

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Indapta Therapeutics receives US FDA fast track designation for lead clinical drug candidate IDP-023 for non-Hodgkin’s lymphoma and myeloma

29 February 2024 - Highly differentiated allogeneic natural killer cell therapy in Phase 1 trial, with initial data expected in second ...

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FDA grants fast track designation to 9MW2821

27 February 2024 - Mabwell announces that its self developed novel antibody drug conjugate targeting Nectin-4 (9MW2821) has been granted fast ...

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Artiva Biotherapeutics receives FDA fast track designation for AlloNK in lupus nephritis

22 February 2024 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to Artiva’s lead ...

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Omnix Medical granted fast track designation by US FDA for its next generation anti-infective OMN6

20 February 2024 - Omnix Medical today announced that the Company has received fast track designation for its novel anti-infective ...

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Medera’s Sardocor announces fast track designation and dosing of 3 patients in first in human HFpEF gene therapy trial

14 February 2024 - In the Phase 1/2A clinical trial for SRD-001, an adeno-associated virus mediated first in human gene therapy ...

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Immuneering receives FDA fast track designation for IMM-1-104 in pancreatic cancer

20 February 2024 - Company expects multiple readouts from its Phase 1/2a clinical trial in 2024. ...

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PepGen receives US FDA fast track designation for PGN-EDODM1 for the treatment of myotonic dystrophy type 1

20 February 2024 - PepGen today announced that the US FDA has granted fast track designation to PGN-EDODM1, an investigational candidate ...

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Disc Medicine receives FDA fast track designation for DISC-0974 for the treatment of anaemia in non-dialysis dependent chronic kidney disease

20 February 2024 - Disc Medicine today announced that the US FDA has granted fast track designation to DISC-0974 for the ...

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Certa Therapeutics’ FT011 granted US FDA fast track for the treatment of systemic sclerosis

19 February 2024 - Certa Therapeutics today announces that the US FDA has granted fast track designation for its investigational therapy ...

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