Galapagos receives fast track designation from FDA for GLPG1972/S201086 in osteoarthritis

27 November 2018 - Galapagos announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of ...

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HighTide Therapeutics receives fast track designation from the U.S. FDA for HTD1801 treating non-alcoholic steatohepatitis

27 November 2018 - HighTide Therapeutics announced that the U.S. FDA has granted fast track designation to its investigational new drug, ...

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Palvella Therapeutics announces FDA fast track designation for PTX-022 for treatment of pachyonychia congenita

12 November 2018 - Palvella Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead product ...

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Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma

7 November 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to selinexor, the Company’s ...

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SpringWorks Therapeutics receives FDA fast track designation for nirogacestat for the treatment of adult patients with desmoid tumours

7 November 2018 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for nirogacestat, an investigational, ...

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Constellation Pharmaceuticals receives FDA fast track designation for CPI-0610 in treatment of myelofibrosis

1 November 2018 - Recently expanded and enhanced MANIFEST Phase 2 trial on-going with proof of concept data expected mid-2019. ...

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Albireo receives FDA fast track designation for A4250

17 October 2018 - Albireo Pharma today announced the U.S. FDA has granted Fast Track designation to lead product candidate ...

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VistaGen Therapeutics receives FDA fast track designation for development of AV-101 as a non-opioid treatment for neuropathic pain

3 October 2018 - Second FDA fast track designation for AV-101 since December 2017 marks another milestone for VistaGen's R&D pipeline. ...

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HighTide Therapeutics receives fast track designation from the U.S. FDA for HTD1801 treating primary sclerosing cholangitis

27 September 2018 - HighTide Therapeutics announced that the U.S. FDA has granted fast track designation to its investigational new drug, ...

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Protagonist Therapeutics announces fast track designation granted by U.S. FDA to hepcidin mimetic PTG-300

27 September 2018 - Designation applies to development for the treatment of chronic anemia in patients with beta-thalassemia. ...

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Aronora's new blood clot treatment receives FDA fast track designation

26 September 2018 - Enzyme that selectively targets blood clots has received FDA fast track designation, allowing for expedited clinical development. ...

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FDA grants QIDP and fast track designations to Cidara Therapeutics’ rezafungin prophylaxis development program

25 September 2018 - Rezafungin designated for the prevention of invasive fungal infections in adults undergoing bone marrow transplantation. ...

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MicuRx announces receipt of FDA’s QIDP and fast track designations for contezolid and contezolid acefosamil

21 September 2018 - MicuRx Pharmaceuticals today announced the receipt of the qualified infectious disease product classification and grant of fast ...

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Adverum Biotechnologies receives fast track designation for ADVM-022 gene therapy for the treatment of wAMD

19 September 2018 - ADVM-022 is a unique single-administration gene therapy delivered intra-vitreally for the treatment of wAMD. ...

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Miransertib (ARQ 092) granted fast track designation for the treatment of PIK3CA-related overgrowth spectrum

13 September 2018 - ArQule today announced that the U.S. FDA has granted fast track designation to miransertib (ARQ 092) for ...

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