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RSS FeedPosted 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 ...
Posted by Michael Wonder on 24 Oct 2022
Acumen’s ACU193, an anti-amyloid beta oligomer antibody, granted FDA fast track designation for Alzheimer's disease
24 October 2022 - Acumen Pharmaceuticals today announced that ACU193, the first clinical stage monoclonal antibody that selectively targets toxic ...
Posted by Michael Wonder on 19 Oct 2022
FDA grants fast track designation to Tvardi Therapeutics’ TTI-101 for hepatocellular carcinoma
19 October 2022 - Tvardi Therapeutics today announced that its lead product, TTI-101, has been granted fast track designation by the ...
Posted by Michael Wonder on 18 Oct 2022
Noema Pharma receives FDA fast track designation for basimglurant (NOE-101) in trigeminal neuralgia
18 October 2022 - Noema Pharma today announces that the US FDA has granted fast track designation to its mGluR5 inhibitor ...
Posted by Michael Wonder on 17 Oct 2022
Mereo BioPharma receives FDA fast track designation for alvelestat for treatment of alpha-1 antitrypsin deficiency-associated lung disease
17 October 2022 - Mereo BioPharma today announced that the US FDA has granted fast track designation for its investigational oral ...
Posted by Michael Wonder on 10 Oct 2022
Nanoscope Therapeutics receives fast track designation by the FDA for MCO-010 for the treatment of retinitis pigmentosa
10 October 2022 - Nanoscope Therapeutics today announced that the US FDA has granted fast track designation to MCO-010, an ...