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RSS FeedPosted by Michael Wonder on 30 Oct 2024
US FDA grants Prolong Pharmaceuticals FDA fast track designation for novel stroke therapy (PP-007) in HEMERA-1 clinical study
30 October 2024 - Prolong Pharmaceuticals announced today that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has received fast track designation ...
Posted by Michael Wonder on 25 Oct 2024
Shionogi receives US FDA fast track designation for the novel anti-respiratory syncytial virus drug candidate S-337395
24 October 2024 - Shionogi announced that the US FDA has granted fast track designation for S-337395, our novel anti-respiratory syncytial ...
Posted by Michael Wonder on 24 Oct 2024
HiberCell receives FDA fast track designation for HC-7366 for the treatment of relapsed or refractory acute myeloid leukaemia
23 October 2024 - HiberCell is pleased to announce that the US FDA has granted fast track designation to HC-7366 for ...
Posted by Michael Wonder on 23 Oct 2024
Cothera Bioscience announces FDA fast track designation for clinical program PC-002
14 October 2024 - Cothera Bioscience is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 21 Oct 2024
Protara Therapeutics granted FDA fast track designation for intravenous choline chloride for patients receiving parenteral support
21 October 2024 - Remain on track to initiate registrational THRIVE-3 trial in Q1, 2025. ...
Posted by Michael Wonder on 17 Oct 2024
Valneva and LimmaTech awarded FDA fast track designation for tetravalent Shigella vaccine candidate S4V
16 October 2024 - Valneva and LimmaTech Biologics announced today that the US FDA has granted fast track designation to ...
Posted by Michael Wonder on 15 Oct 2024
Lantern Pharma’s investigational drug candidate, LP-184, receives fast track designation in glioblastoma from the FDA
15 October 2024 - A Phase 1b/2a clinical trial for recurrent glioblastoma is targeted to start in late 2024/early 2025. ...
Posted by Michael Wonder on 15 Oct 2024
The US FDA grants fast track designation to Coherent Biopharma’s CBP-1008
10 October 2024 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1008 for injection (CBP-1008) ...
Posted by Michael Wonder on 10 Oct 2024
FDA grants fast track designation for biomarker guided DB104 (liafensine) in patients with treatment resistant depression
9 October 2024 - Denovo Biopharma today announced that the US FDA has granted fast track designation for DB104 (liafensine) being ...
Posted by Michael Wonder on 09 Oct 2024
CPO301 receives fast track designation from the US FDA
8 October 2024 - The board of directors of CSPC Pharmaceutical Group is pleased to announce that CPO301, a first ...
Posted by Michael Wonder on 03 Oct 2024
Volastra Therapeutics granted FDA fast track designation for novel KIF18A inhibitor in ovarian cancer
2 October 2024 - Volastra Therapeutics today announced that the US FDA has granted fast track designation to VLS-1488, the company’s ...
Posted by Michael Wonder on 02 Oct 2024
Sagimet receives FDA breakthrough therapy designation for denifanstat in MASH
1 October 2024 - Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH. ...
Posted by Michael Wonder on 02 Oct 2024
Zilganersen granted US FDA fast track designation for people living with Alexander disease
1 October 2024 - Zilganersen is the first investigational medicine in clinical development for adults and children living with Alexander disease, ...
Posted by Michael Wonder on 27 Sep 2024
FDA grants fast track designation to PTC518 Huntington's disease program
26 September 2024 - PTC Therapeutics announced today that the FDA has granted fast track designation to the PTC518 program for ...
Posted by Michael Wonder on 24 Sep 2024
Elevation Oncology receives fast track designation from the FDA for EO-3021 for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction cancer expressing Claudin 18.2
23 September 2024 - Elevation Oncology today announced that the US FDA has granted fast track designation to EO-3021, a differentiated ...