Assembly Biosciences announces FDA fast track designation granted to ABI-H2158 for the treatment of chronic hepatitis B virus infection

9 July 2020 - Assembly Biosciences today announced that the U.S. FDA has granted fast track designation to ABI-H2158 (2158) for ...

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MetVital announces FDA fast track designation of anhydrous enol-oxaloacetate for the treatment of patients with newly diagnosed glioblastoma multiforme

1 July 2020 - MetVital today announces that the U.S. FDA has notified MetVital that its lead drug candidate, "Anhydrous ...

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Sun BioPharma receives FDA fast track designation for SBP-101

30 June 2020 - Sun BioPharma today announced receipt of fast track designation from the U.S. FDA for its lead product, ...

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Nordic Nanovector's Betalutin receives fast track designation from US FDA for marginal zone lymphoma

29 June 2020 - Nordic Nanovector today announces that the US FDA has granted fast track designation for investigating Betalutin (177Lu ...

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NeuroRx and Relief Therapeutics announce fast track designation granted by the FDA to RLF-100 (aviptadil) for the treatment of respiratory distress in COVID-19

24 June 2020 - At the FDA’s request, NeuroRx is submitting an expanded access policy enabling physicians to request RLF-100 for ...

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Renibus Therapeutics receives FDA fast track designation for RBT-9 treatment in COVID-19

23 June 2020 - Renibus Therapeutics announced today that it has been granted fast track designation by the FDA for RBT-9 ...

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Polynoma receives FDA fast track designation for its melanoma cancer vaccine seviprotimut-L

23 June 2020 - Polynoma announces that the U.S. FDA has granted its application for fast track designation of seviprotimut-L, ...

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Linnaeus Therapeutics granted U.S. FDA fast track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on anti-PD-1/L1 therapy

18 June 2020 - Company Conducting Ongoing Phase 1/2 Study of LNS8801. ...

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Chi-Med announces fruquintinib granted U.S. FDA fast track designation for metastatic colorectal cancer

18 June 2020 - Hutchison China MediTech today announces that the U.S. FDA has granted fast track designation for the development ...

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Ipsen receives FDA fast track designation for liposomal irinotecan (Onivyde) as a first-line combination treatment for metastatic pancreatic cancer

17 June 2020 - Final analysis of the Phase 1/2 clinical study to be presented as a late-breaking virtual presentation at ...

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ZZ Biotech announces FDA fast track designation for stroke program

12 June 2020 - ZZ Biotech today announced that the US FDA has designated the investigation of the company’s experimental drug ...

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TVAX Biomedical receives fast track designation from the FDA for brain cancer

4 June 2020 - TVAX Biomedical announced today receipt of fast track designation from the U.S. FDA for the use of ...

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Cardiff Oncology announces fast track designation granted by the FDA to onvansertib for second-line treatment of KRAS mutated colorectal cancer

28 May 2020 - Fast Track designation for onvansertib in KRAS mutated metastatic colorectal cancer underscores the urgent need for new ...

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Cellectar receives FDA fast track designation for CLR 131 in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinaemia

26 May 2020 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in lymphoplasmacytic ...

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Protara Therapeutics receives fast track designation from U.S. FDA for intravenous choline chloride for the treatment of intestinal failure associated liver disease

26 May 2020 - Protara Therapeutics today announced that the U.S. FDA has granted fast track designation to intravenous choline chloride ...

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