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RSS FeedPosted by Michael Wonder on 06 Dec 2022
Vistagen receives FDA fast track designation for development of PH10 to treat major depressive disorder
6 December 2022 - Vistagen today announced the US FDA has granted fast track designation for the development of PH10, ...
Posted by Michael Wonder on 06 Dec 2022
Istesso announces FDA fast track and orphan drug designation for MBS2320
5 December 2022 - Istesso today announces that the US FDA has granted fast track designation for Istesso’s investigational metabolic ...
Posted by Michael Wonder on 06 Dec 2022
IDEAYA Biosciences receives fast track designation for darovasertib combination therapy with crizotinib for the treatment of metastatic uveal melanoma
5 December 2022 - Fast track designation granted by US FDA for evaluation of darovasertib in combination with crizotinib in adult ...
Posted 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 ...