Candel Therapeutics receives FDA fast track designation for CAN-2409 in non-small-cell lung cancer

17 April 2023 - Fast track designation has the potential to facilitate the development and expedite the US FDA review of ...

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SAB Biotherapeutics granted fast track designation from FDA for SAB-176 influenza immunotherapy with high cross-reactivity to multiple strains of influenza

13 April 2023 - FDA greenlights advancement of SAB-176 Phase 2b trial and manufacturing approach to address influenza strain change. ...

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Kala Pharmaceuticals receives FDA fast track designation for KPI-012, a human MSC-S therapy for persistent corneal epithelial defect

12 April 2023 - Kala Pharmaceuticals today announced that the US FDA has granted fast track designation for Kala’s human mesenchymal ...

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RegenxBio receives FDA fast track designation for RGX-202, a novel gene therapy candidate for the treatment of Duchenne muscular dystrophy

11 April 2023 - RGX-202 is a potential one-time AAV therapeutic for the treatment of Duchenne and includes an optimised transgene ...

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Enanta Pharmaceuticals receives FDA fast track designation for EDP-323, its oral, L-protein inhibitor in development for the treatment of respiratory syncytial virus

6 April 2023 - Enanta Pharmaceuticals today announced that the US FDA has granted fast track designation for EDP-323, Enanta’s ...

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Caribou Biosciences announces FDA granted fast track designation to CB-011, an allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma

4 April 2023 - CaMMouflage Phase 1 trial for CB-011 enrolling patients with relapsed or refractory multiple myeloma at dose level ...

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Verismo Therapeutics secures fast track designation from the US FDA for SynKIR-110

5 April 2023 - SynKIR-110 addresses gaps in treatment options for those with malignant pleural mesothelioma, a rare and aggressive ...

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Shionogi receives US FDA fast track designation for ensitrelvir fumaric acid, an investigational oral anti-viral for COVID-19

4 April 2023 - Shionogi today announced that the US FDA has granted fast track designation for their investigational COVID-19 ...

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Renovion receives FDA fast track designation for ARINA-1 for the prevention of BOS progression in lung transplant patients

30 March 2023 - Renovion announced today that the US FDA has granted fast track designation to ARINA-1 for the prevention ...

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EpicentRx receives fast track designation from the US FDA for lead asset, RRx-001, to prevent/attenuate chemotherapy and radiation treatment induced severe oral mucositis

29 March 2023 - EpicentRx announced today that the US FDA granted fast track designation to RRx-001, a direct NLRP3 inhibitor ...

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Prestige Biopharma receives FDA fast track designation for PBP1510 in the treatment of pancreatic cancer

21 March 2023 - Prestige Biopharma has received fast track designation from the US FDA for PBP1510 (ulenistamab), in the ...

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Arrowhead receives FDA fast track designation for ARO-APOC3

20 March 2023 - Arrowhead Pharmaceuticals today announced the US FDA has granted fast track designation to ARO-APOC3 for reducing ...

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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 ...

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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 ...

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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 ...

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