Cadrenal Therapeutics granted FDA fast track designation for tecarfarin for prevention of systemic thromboembolism of cardiac origin in patients with end stage renal disease and atrial fibrillation

23 January 2023 - Cadrenal Therapeutics announced today that the US FDA has granted a fast track designation to tecarfarin ...

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DualityBio announces DB-1303 granted fast track designation by the US FDA for the treatment of advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression

20 January 2023 - Duality Biologics announced that the US FDA has granted fast track designation to DB-1303 for the treatment ...

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MedPacto receives US FDA fast track designation for vactosertib for the treatment of metastatic osteosarcoma

17 January 2023 - MedPacto announced that the US FDA has granted fast track designation to vactosertib as a monotherapy ...

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Evaxion receives FDA fast track designation for personalised cancer immunotherapy

19 January 2023 - Evaxion Biotech today announced that the US FDA has granted fast track designation for the Company’s ...

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Avidity Biosciences granted FDA fast track designation for AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy

18 January 2023 - Avidity Biosciences today announced that the US FDA has granted fast track designation to AOC 1020 for ...

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Treadwell Therapeutics announces fast track designation granted by the FDA to CFI-402257 for the treatment of ER+/HER2- breast cancer

10 January 2023 - Treadwell Therapeutics announced today that the US FDA has granted fast track designation to CFI-402257, a best ...

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UNION therapeutics receives FDA fast track designation for oral orismilast for the treatment of moderate to severe hidradenitis suppurativa

10 January 2023 - Orismilast is a high potency PDE4 inhibitor with broad anti-inflammatory properties also in development for oral ...

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Bicycle Therapeutics announces FDA fast track designation granted to BT8009 for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer

4 January 2023 - Bicycle Therapeutics today announced that the US FDA has granted fast track designation to Bicycle’s BT8009 ...

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Azafaros receives fast track designation for lead asset AZ-3102

5 January 2023 - Azafaros today announced that the FDA has granted fast track designation for the investigation of AZ-3102 for ...

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Sedana Medical receives FDA fast track designation in the US

4 January 2023 - Sedana Medical today announces that the US FDA has granted fast track designation for the evaluation of ...

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FDA grants fast track to Edesa Biotech's ARDS drug candidate

20 December 2022 - Edesa Biotech has received fast track designation from the US FDA for its monoclonal antibody candidate, EB05.  ...

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PharmaJet Partner Immunomic Therapeutics receives FDA fast track designation for pDNA vaccine for skin cancer

13 December 2022 - Vaccine exclusively delivered with the PharmaJet Stratis needle-free injection system. ...

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Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza

9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...

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Moleculin granted FDA fast track designation of WP1122 for the treatment of glioblastoma multiforme

7 December 2022 - Moleculin Biotech today announced that the US FDA has granted fast track designation of WP1122 for the ...

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SQZ Biotechnologies receives FDA fast track designation for its eAPC therapeutic candidate for treatment of HPV16 positive tumours

6 December 2022 - Stable disease observed in two out of four evaluable patients in eAPC Phase 1/2 trial including a ...

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