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RSS FeedPosted 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 ...
Posted by Michael Wonder on 06 Oct 2022
Lilly receives US FDA fast track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related co-morbidities
6 October 2022 - The fast track designation accelerates tirzepatide's path to US FDA submission for the treatment of adults ...
Posted by Michael Wonder on 05 Oct 2022
Immutep receives FDA fast track designation for LAG-3 therapeutic eftilagimod alfa for first-line non-small-cell lung cancer
4 October 2022 - Based on the encouraging Phase 2 clinical data for PD-L1 all-comers presented at ASCO 2022. ...
Posted by Michael Wonder on 04 Oct 2022
Cue Biopharma granted FDA fast track designation for CUE-101 for the treatment of recurrent/metastatic head and neck squamous cell carcinoma
4 October 2022 - Cue Biopharma announced today that the U.S. FDA has granted fast track designation to CUE-101, its ...
Posted by Michael Wonder on 03 Oct 2022
Viewpoint Molecular Targeting announces VMT-alfa-NET granted US FDA fast track destination for the treatment of neuroendocrine tumours
3 October 2022 - Viewpoint Molecular Targeting today announced that the US FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 03 Oct 2022
Calithera receives FDA fast track designation for sapanisertib for the treatment of NRF2 mutated squamous lung cancer
3 October 2022 - Enrollment on-going in Phase 2 study evaluating sapanisertib, a dual mTORC1/2 inhibitor, in patients with squamous ...
Posted by Michael Wonder on 29 Sep 2022
Fore Biotherapeutics announces fast track designation granted by FDA to FORE8394 for the treatment of cancers harbouring BRAF class 1 and class 2 alterations
28 September 2022 - FORE8934 currently being evaluated in Phase 1/2a trial for the treatment of advanced solid and CNS tumours ...
Posted by Michael Wonder on 27 Sep 2022
Ayala Pharmaceuticals announces fast track designation granted by US FDA for AL102 in progressing desmoid tumours
27 September 202 - Ayala Pharmaceuticals today announced that the US FDA has granted fast track designation for AL102 for the ...