Akari Therapeutics receives FDA fast track designation for nomacopan for paediatric haematopoietic stem cell transplant-related thrombotic microangiopathy

14 August 2019 - Proposed pivotal trial of nomacopan in paediatric patients with HSCT-TMA expected to start Q4 2019 in North ...

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Windtree announces FDA fast track designation for istaroxime

13 August 2019 - Fast track designation highlights the potential for istaroxime to address unmet medical needs of patients hospitalised with ...

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Momenta Pharmaceuticals announces fast track designation for M281 (nipocalimab) in haemolytic disease of the foetus and newborn

30 July 2019 - Momenta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for M281, Momenta’s ...

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NeuroVive’s NeuroSTAT project receives FDA fast track designation

27 July 2019 - NeuroVive Pharmaceutical today announced that the company’s candidate drug NeuroSTAT, in development for treatment of moderate ...

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Matinas BioPharma receives qualified infectious disease product and fast track designations from U.S. FDA for MAT2203 for the treatment of cryptococcal meningitis

25 July 2019 - Fourth QIDP and fast track designations granted by FDA for MAT2203. ...

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Cellectar receives FDA fast track designation for CLR 131 in diffuse large B-cell lymphoma

9 July 2019 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in relapsed ...

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Prevail Therapeutics receives U.S. FDA fast track designation for PR001 for the treatment of Parkinson’s disease patients with a GBA1 mutation

8 July 2019 - Company plans to initiate Phase 1/2 clinical trial in the second half of 2019. ...

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Arrowhead Pharmaceuticals receives fast track designation for ARO-AAT for treatment of alfa-1 liver disease

27 June 2019 - Arrowhead Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to ARO-AAT, the company’s ...

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U.S. FDA grants fast track designation to empagliflozin for the treatment of chronic heart failure

26 June 2019 - FDA's Fast Track designation for empagliflozin underscores the urgent need for new potential treatment options for the ...

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FDA grants fast track designation for Torque's first deep-primed T cell cancer immunotherapy program, TRQ-1501

18 June 2019 - Torque announced today that the U.S. FDA granted fast track designation for Torque's first Deep-Primed T cell ...

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Abeona Therapeutics receives FDA fast track designation for ABO-202 AAV9 gene therapy in CLN1 disease

18 June 2019 - Abeona Therapeutics today announced that the U.S. Food and FDA has granted fast track designation to its ...

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Sierra announces momelotinib granted FDA fast track designation

5 June 2019 - Fast Track designation highlights the potential for momelotinib to address the significant unmet needs of patients with ...

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SpringWorks Therapeutics announces FDA fast track designation for PD-0325901 for the treatment of a severe form of neurofibromatosis type 1

3 June 2019 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for PD-0325901, an investigational, ...

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Zymeworks' lead asset, ZW25, granted fast track designation from the FDA

29 May 2019 - Zymeworks today announced that the U.S. FDA has granted fast track designation to ZW25, a novel azymetric ...

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Arvinas receives fast track designation for its targeted protein degrader ARV-110 as a treatment for men with metastatic castration-resistant prostate cancer

29 May 2019 - Arvinas today announced that its lead Protac protein degrader, ARV-110, has been granted fast track designation by ...

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