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RSS FeedPosted by Michael Wonder on 15 Feb 2023
Kinnate Biopharma receives fast track designation from the US FDA for KIN-3248, an investigational pan FGFR inhibitor
14 February 2023 - Kinnate Biopharma today announced that the US FDA has granted fast track designation for Kinnate’s investigational ...
Posted by Michael Wonder on 13 Feb 2023
IASO Bio announces CT103A granted regenerative medicine advanced therapy and fast track designations by the FDA
12 February 2023 - IASO Biotherapeutics today announced that the US FDA has granted both regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 06 Feb 2023
Endogena Therapeutics receives US FDA fast track designation for EA-2353 for the treatment of retinitis pigmentosa
6 February 2023 - Endogena Therapeutics announced today that the US FDA has designated the investigation of EA-2353 for the treatment ...
Posted by Michael Wonder on 01 Feb 2023
Artiva Biotherapeutics receives FDA fast track designation for AB-101
31 January 2023 - Granted fast track designation by US FDA for the treatment of relapsed/refractory non-Hodgkin lymphoma of B cell ...
Posted by Michael Wonder on 31 Jan 2023
Ionis receives FDA fast track designation for olezarsen in patients with familial chylomicronaemia syndrome
31 January 2023 - If approved, olezarsen would be the first approved treatment for familial chylomicronaemia syndrome in the US. ...
Posted by Michael Wonder on 31 Jan 2023
Reneo Pharmaceuticals receives fast track designation from the FDA for mavodelpar (REN001) in a genotype of long-chain fatty acid oxidation disorder
31 January 2023 - Reneo Pharmaceuticals today announced that the US FDA has granted mavodelpar (REN001) fast track designation for long ...
Posted by Michael Wonder on 30 Jan 2023
Nanoscope Therapeutics receives fast track designation by the FDA for MCO-010 for the treatment of Stargardt disease
30 January 2023 - Nanoscope Therapeutics today announced that the US FDA has granted fast track designation to MCO-010, an ...
Posted by Michael Wonder on 26 Jan 2023
Syros receives fast track designation from the FDA for tamibarotene for the treatment of higher-risk myelodysplastic syndrome
26 January 2023 - Currently evaluating tamibarotene in combination with azacitidine pivotal SELECT-MDS-1 Phase 3 clinical trial in newly diagnosed higher-risk myelodysplastic ...
Posted by Michael Wonder on 23 Jan 2023
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 ...
Posted by Michael Wonder on 22 Jan 2023
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 ...
Posted by Michael Wonder on 21 Jan 2023
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 ...
Posted by Michael Wonder on 19 Jan 2023
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 ...
Posted by Michael Wonder on 18 Jan 2023
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 ...
Posted by Michael Wonder on 11 Jan 2023
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 ...
Posted by Michael Wonder on 11 Jan 2023
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 ...