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RSS FeedPosted by Michael Wonder on 11 Nov 2023
Rznomics secures fast track designation from the US FDA for RZ-001
10 November 2023 - Rznomics announced today that it has received fast track designation from the US FDA for RZ-001, for ...
Posted by Michael Wonder on 06 Nov 2023
AviadoBio announces FDA IND clearance and fast track designation for AVB-101 for the treatment of frontotemporal dementia with progranulin mutations
6 November 2023 - AVB-101 is an investigational gene therapy delivered as a one time infusion directly to the brain, enabling ...
Posted by Michael Wonder on 31 Oct 2023
Cessation Therapeutics receives FDA fast track designation for CSX-1004 for prevention of fentanyl and fentanyl analogue overdose
31 October 2023 - If approved, CSX-1004 would be the first FDA approved therapy for prevention of fentanyl-related overdose. ...
Posted by Michael Wonder on 30 Oct 2023
Sellas Life Sciences receives fast track designation from FDA for SLS009 for treatment of relapsed/refractory peripheral T-cell lymphomas
30 October 2023 - LS009 demonstrated promising efficacy in Phase 1 Study with 36.4% clinical response in relapsed/refractory peripheral T-cell lymphomas; ...
Posted by Michael Wonder on 27 Oct 2023
Altimmune granted fast track designation by FDA for pemvidutide for the treatment of non-alcoholic steatohepatitis
26 October 2023 - Altimmune today announced that the US FDA has granted fast track designation to its clinical program ...
Posted by Michael Wonder on 26 Oct 2023
Oncternal Therapeutics announces FDA granted fast track designation for ONCT-534 for the treatment of metastatic castration-resistant prostate cancer
26 October 2023 - Oncternal Therapeutics today announced that the US FDA has designated ONCT-534, its novel dual-acting androgen receptor inhibitor, ...
Posted by Michael Wonder on 23 Oct 2023
NervGen Pharma receives fast track designation for NVG-291 for the treatment of individuals with spinal cord injury
23 October 2023 - NervGen Pharma today announced that the US FDA has granted fast track designation for its proprietary lead ...
Posted by Michael Wonder on 20 Oct 2023
FDA grants fast track designation to ANPD001, autologous investigational cell therapy for the treatment of Parkinson's disease
19 October 2023 - Aspen Neuroscience today announced that the US FDA has granted fast track designation for ANPD001 for the ...
Posted by Michael Wonder on 17 Oct 2023
Diakonos Oncology awarded FDA fast track designation for innovative dendritic cell vaccine for glioblastoma
17 October 2023 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the Company’s unique ...
Posted by Michael Wonder on 12 Oct 2023
MimiVax granted fast track designation from FDA for SurVaxM for newly diagnosed glioblastoma
12 October 2023 - MimiVax announced today that the US FDA has granted fast track designation to MimiVax’s SurVaxM vaccine ...
Posted by Michael Wonder on 12 Oct 2023
South Rampart Pharma receives US FDA fast track designation for SRP-001 for acute pain
12 October 2023 - The fast track designation accelerates SRP-001's path to US FDA submission for the treatment of acute pain. ...
Posted by Michael Wonder on 10 Oct 2023
ImmPACT Bio granted FDA fast track designation for IMPT-514 for the treatment of both active, refractory lupus nephritis and systemic lupus erythematosus
10 October 2023 - IMPT-514 is the first CD19/CD20 CAR T-cell therapy in development for lupus. ...
Posted by Michael Wonder on 05 Oct 2023
Agomab receives FDA fast track designation for AGMB-129 in fibrostenosing Crohn’s disease
5 October 2023 - Global 12 week Phase 2a trial will evaluate Agomab’s oral GI restricted small molecule ALK5 inhibitor in ...
Posted by Michael Wonder on 05 Oct 2023
Vedanta Biosciences announces first patient dosed in Phase 2 clinical trial of VE202 for the treatment of ulcerative colitis and receives fast track designation
4 October 2023 - VE202 is an orally administered, rationally-defined bacterial consortium candidate for the treatment of ulcerative colitis. ...
Posted by Michael Wonder on 03 Oct 2023
Oxford BioTherapeutics announces partner Boehringer Ingelheim received US FDA fast track designation for BI 764532 for the treatment of extensive stage small cell lung cancer and extrapulmonary neuroendocrine cancers
3 October 2023 - BI 764532 is an investigational T-cell engager that redirects T cells towards cancer cells expressing the DLL3 ...