Oblato announces fast track designation of OKN-007 for diffuse intrinsic pontine glioma from the FDA

3 March 2021 - Oblato announces that the FDA granted fast track designation of OKN-007, the proprietary drug for diffuse intrinsic ...

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Celsion Corporation receives FDA fast track designation for GEN-1 in advanced ovarian cancer

22 February 2021 - Designation provides potential for an expedited regulatory review.. ...

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Efanesoctocog alfa granted FDA fast track designation for treatment of haemophilia A

18 February 2021 - Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential ...

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Targovax receives fast track designation for ONCOS-102

15 February 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in malignant ...

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Ellodi Pharmaceuticals announces fast track designation granted by the FDA to APT-1011 for the treatment of eosinophilic osophagitis

8 February 2021 - Ellodi Pharmaceuticals today announced that APT-1011 (fluticasone propionate oral disintegrating tablet) has been granted fast track designation ...

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Theratechnologies’ lead peptide drug conjugate TH1902 receives FDA fast track designation for the treatment of sortilin-expressing cancers

4 February 2021 - Theratechnologies is pleased to announce that the United States FDA has granted fast track designation to TH1902 ...

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Asana BioSciences’ gusacitinib granted FDA fast track designation for moderate to severe chronic hand eczema

4 February 2021 - Asana BioSciences announced today that the U.S. FDA has granted fast track designation to Asana’s gusacitinib (ASN002), ...

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Cerecor announces fast track designation for CERC-803 for the treatment of leukocyte adhesion deficiency type II

2 February 2021 - Cerecor today announced that the U.S. FDA has granted fast track designation to CERC-803 for the treatment ...

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Phase 1 drug candidate GLR2007 developed by Gan & Lee has been granted fast track designation by the U.S. FDA

29 January 2021 - Gan & Lee Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for GLR2007, ...

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MeiraGTx announces AAV-CNGA3 granted fast track designation by U.S. FDA for treatment of achromatopsia

26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy ...

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FDA grants toripalimab fast track designation for mucosal melanoma

25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...

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Metacrine announces FDA fast track designation for MET642 as a treatment of NASH

19 January 2021 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET642, the company’s second ...

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FDA grants fast track designation to padeliporfin ImPACT for Steba biotech

15 January 2021 - Ambitious development program for multiple solid tumours with high unmet need, starting with low grade upper tract ...

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Inhibrx granted fast track designation for INBRX-109 for the treatment of unresectable or metastatic conventional chondrosarcoma patients

13 January 2020 - Registration enabling study expected to begin dosing in the second or third quarter of this year. ...

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Innovation Pharmaceuticals’ brilacidin for the treatment of COVID-19 receives FDA fast track designation

14 January 2021 - Innovation Pharmaceuticals is pleased to announce that the U.S. FDA has designated as a fast track development ...

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