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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Imara announces FDA fast track designation for IMR-687 for the treatment of sickle cell disease

29 May 2019 - Imara today announced that the U.S. FDA has granted fast track designation to IMR-687, the company’s ...

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U.S. FDA grants priority review for Vascepa (icosapent ethyl) supplemental new drug application seeking cardiovascular risk reduction indication

29 May 2019 - PDUFA date assigned is 28 September 2019, four months sooner than expected. ...

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Sermonix receives FDA fast track designation for investigational drug lasofoxifene

28 May 2019 - Designation allows for expedited development and review of lasofoxifene as a potential precision medicine treatment for women ...

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Athersys announces fast track designation from FDA for MultiStem program for acute respiratory distress syndrome

14 May 2019 - Athersys announced today that its clinical program evaluating MultiStem cell therapy for the treatment of acute respiratory ...

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Homology Medicines announces FDA fast track designation for HMI-102 gene therapy development candidate for adults with PKU

14 May 2019 - Company provides details of pheNIX, the first gene therapy trial for PKU, and remains on track to ...

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