FDA grants fast track designation to Arena Pharmaceuticals' APD418 for development in decompensated heart failure patients

16 January 2020 - Arena Pharmaceuticals today announced that the U.S. FDA granted fast track designation for APD418, a β3-adrenergic ...

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Novavax granted fast track designation for NanoFlu in older adults

15 January 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NanoFlu, its recombinant quadrivalent ...

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Imago receives fast track designation from U.S. FDA for bomedemstat for treatment of essential thrombocythemia

13 January 2020 - Imago BioScience today announced that the U.S. FDA has granted fast track designation for the development ...

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Meissa Vaccines receives U.S. FDA fast track designation for respiratory syncytial virus vaccine, MV-012-968

10 January 2020 - Meissa Vaccines announced today that the U.S. FDA has granted fast track designation to MV-012-968, an ...

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Minoryx Therapeutics receives US FDA fast-track designation for leriglitazone in the treatment of X-ALD

9 January 2020 - Leriglitazone (MIN-102), a novel, brain penetrant, orally bioavailable and selective PPARγ agonist, is currently in late-stage development ...

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ReNetX Bio receives fast track designation from U.S. FDA

8 January 2020 - Potential first-in-class therapy for chronic spinal cord injury. ...

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BridgeBio Pharma’s QED Therapeutics receives fast track designation for infigratinib in adults with first-line advanced or metastatic cholangiocarcinoma and orphan drug designation for infigratinib for treatment of cholangiocarcinoma

6 January 2020 - The PROOF trial, a Phase 3 trial of infigratinib in first-line cholangiocarcinoma, is currently enrolling. ...

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Orphazyme’s arimoclomol receives US fast track designation in sporadic inclusion body myositis

18 December 2019 - Orphazyme today received fast track designation from the US FDA for the development of arimoclomol for the ...

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Kura Oncology receives fast track designation for tipifarnib in HRAS mutant HNSCC and provides enrolment guidance for AIM-HN trial

16 December 2019 - Registration-directed AIM-HN trial expected to complete enrolment in first quarter of 2021. ...

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Salarius Pharmaceuticals receives FDA fast track designation for lead drug candidate, seclidemstat, in relapsed or refractory Ewing sarcoma

16 December 2019 - Phase 1/2 clinical study now underway; Salarius targeting key safety and efficacy data milestones in 2020. ...

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Equillium granted U.S. FDA fast track designation for itolizumab for the treatment of lupus nephritis

9 December 2019 - Equillium today announced that the U.S. FDA has granted fast track designation for itolizumab for the ...

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Dermira receives fast track designation from FDA for lebrikizumab for the treatment of atopic dermatitis

10 December 2019 - Dermira today announced that the U.S. FDA has granted fast track designation for lebrikizumab, its novel, investigational treatment ...

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U.S. FDA grants VistaGen Therapeutics fast track designation for PH94B for treatment of social anxiety disorder

10 December 2019 - VistaGen's PH94B is the first drug candidate to be granted U.S. FDA fast track designation for treatment ...

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Alector announces FDA fast track designation granted to AL001 for the treatment of patients with frontotemporal dementia

5 December 2019 - Alector today announced that the U.S. FDA has granted fast track designation for its investigational therapeutic, ...

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Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome

18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) ...

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