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RSS FeedPosted by Michael Wonder on 19 Mar 2023
Prestige Biopharma's pancreatic cancer drug candidate put on FDA fast track
17 March 2023 - Prestige Biopharma said on Thursday that its new pancreatic cancer antibody drug candidate, PBP1510, (ulenistamab), was ...
Posted by Michael Wonder on 06 Mar 2023
Ikena Oncology receives FDA fast track designation for novel AHR antagonist IK-175 in combination with nivolumab to treat urothelial carcinoma
6 March 2023 - Ikena Oncology today announced that the US FDA has granted fast track designation for IK-175, the ...
Posted by Michael Wonder on 21 Feb 2023
Icosavax granted FDA fast track designation for IVX-A12
21 February 2023 - Icosavax today announced the US FDA has granted fast track designation for IVX-A12, a bivalent respiratory syncytial ...
Posted by Michael Wonder on 21 Feb 2023
Biohaven's taldefgrobep alfa receives FDA fast track designation for spinal muscular atrophy
21 February 2023 - Taldefgrobep alfa, a myostatin-targeting biologic investigational agent, in Phase 3 development to increase muscle mass for ...
Posted 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 ...