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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Oct 2023
Avenge Bio receives FDA fast track designation for AVB-001, a novel cell therapy leveraging the LOCOcyte immunotherapy platform
2 October 2023 - Regulatory designation includes platinum-resistant, high grade serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube. ...
Posted by Michael Wonder on 27 Sep 2023
ABM Therapeutics' ABM-1310 granted fast track designation by the FDA following orphan drug designation
26 September 2023 - ABM Therapeutics is pleased to announce today that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 27 Sep 2023
IDEAYA receives fast track designation for potential first in class PARG inhibitor, IDE161, for treatment of pretreated, platinum-resistant advanced or metastatic ovarian cancer patients having tumours with BRCA1/2 mutations
26 September 2023 - On-going Phase 1 expansion, with focus in ER positive, HER2 negative, HRD positive breast cancer, HRD positive ...
Posted by Michael Wonder on 27 Sep 2023
Mythic Therapeutics receives FDA fast track designation for MYTX-011 for patients with non-small cell lung cancer with cMET over-expression
26 September 2023 - This designation encompasses non-small-cell lung cancer patients with any level of cMET over-expression, including low and intermediate, ...
Posted by Michael Wonder on 22 Sep 2023
89bio announces US FDA has granted breakthrough therapy designation for pegozafermin in non-alcoholic steatohepatitis
21 September 2023 - Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of ...
Posted by Michael Wonder on 21 Sep 2023
Disc Medicine receives FDA fast track designation for MWTX-003 for the treatment of polycythemia vera
20 September 2023 - Disc Medicine today announced that the US FDA has granted fast track designation to MWTX-003 for the ...
Posted by Michael Wonder on 18 Sep 2023
Kymera Therapeutics receives US FDA fast track designation for KT-333, a first in class, investigational STAT3 degrader for the treatment of relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma
18 September 2023 - KT-333 Phase 1 oncology trial ongoing with an update including initial evaluation of its clinical anti-tumour activity ...