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RSS FeedPosted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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. ...
Posted by Michael Wonder on 29 Nov 2022
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. ...
Posted by Michael Wonder on 28 Nov 2022
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 ...
Posted by Michael Wonder on 23 Nov 2022
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 ...
Posted by Michael Wonder on 23 Nov 2022
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 ...
Posted by Michael Wonder on 08 Nov 2022
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 ...
Posted by Michael Wonder on 08 Nov 2022
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 ...
Posted by Michael Wonder on 06 Nov 2022
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 ...
Posted by Michael Wonder on 04 Nov 2022
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 ...
Posted by Michael Wonder on 01 Nov 2022
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 ...
Posted by Michael Wonder on 01 Nov 2022
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 ...
Posted by Michael Wonder on 27 Oct 2022
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. ...
Posted by Michael Wonder on 27 Oct 2022
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 ...