FDA grants fast track designation to Nuvectis Pharma's NXP800 for the treatment of platinum-resistant, ARID1A mutated ovarian carcinoma

1 December 2022 - Nuvectis Pharma today announced that the US FDA has granted fast track designation to NXP800 for the ...

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Oncolytics Biotech receives FDA fast track designation for the treatment of advanced/metastatic pancreatic cancer

1 December 2022 - FDA fast rack designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective ...

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Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy

29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...

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Aravive announces fast track designation of batiraxcept for treatment of clear cell renal cell carcinoma

29 November 2022 - FDA decision based on new Phase 1b data. ...

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Kintara Therapeutics granted fast track designation from FDA for REM-001 for cutaneous metastatic breast cancer

28 November 2022 - Kintara Therapeutics today announced that the US FDA has granted fast track designation to Kintara's REM-001 ...

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Palisade Bio is granted fast track designation from the US FDA for LB1148 for accelerated return of bowel function following GI surgery

22 November 2022 - Palisade Bio today announced that the US FDA has granted fast track designation to LB1148 for ...

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Pacylex granted FDA fast track designation for PCLX-001 for the treatment of relapsed or refractory acute myeloid leukaemia

22 November 2022 - Pacylex today announced that the US FDA has granted PCLX-001 fast track designation for the treatment of ...

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Guard Therapeutics granted FDA fast track designation for RMC-035

8 November 2022 - Guard Therapeutics today announces that the US FDA has granted RMC-035 (ROSgard) fast track designation for reducing ...

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Immunomic Therapeutics receives FDA fast track designation for ITI-3000, a pDNA vaccine, in development for the treatment of Merkel cell carcinoma

8 November 2022 - Immunomic Therapeutics today announced that the US FDA has granted fast track designation to the ITI-3000 program ...

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HLB's US subsidiary scores FDA fast track designation for Merkel cell cancer vaccine

4 November 2022 - HLB said on Friday that the anti-cancer vaccine candidate ITI-3000 aiming to treat Merkel cell cancer ...

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Codagenix receives FDA fast track designation for live attenuated, intranasal RSV vaccine candidate CodaVax-RSV

2 November 2022 - Codagenix today announced that the US FDA has granted fast track designation to CodaVax-RSV, an intranasal, live ...

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Vigil Neuroscience receives FDA fast track designation for VGL101 for the treatment of patients with ALSP

1 November 2022 - Vigil Neuroscience today announced that the US FDA has granted fast track designation to VGL101 for ...

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Dyne Therapeutics receives FDA fast track designation for DYNE-251 for the treatment of Duchenne muscular dystrophy

31 October 2022 - Company anticipates reporting data from global, multiple ascending dose DELIVER clinical trial in the second half ...

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Myeloid Therapeutics announces FDA fast track designation for MT-101 for the treatment of CD5 positive relapsed/refractory PTCL

27 October 2022 - MT-101 is the first mRNA engineered CAR monocyte therapy to be dosed in humans. ...

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ITM receives FDA fast track designation for radionuclide therapy candidate ITM-11 (Lutetium Lu 177 edotreotide) in neuroendocrine tumours (GEP-NETs)

27 October 2022 – ITM Isotope Technologies today announced that the US FDA has granted the company fast track designation ...

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