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RSS FeedPosted by Michael Wonder on 18 Nov 2024
Vaderis receives FDA fast track designation for VAD044 for the treatment of hereditary haemorrhagic telangiectasia
18 November 2024 - Vaderis Therapeutics today announces that the US FDA has designated the allosteric AKT inhibitor VAD044 a fast ...
Posted by Michael Wonder on 18 Nov 2024
Alentis receives FDA fast track designation for ALE.P02 for the treatment of CLDN1 positive squamous solid tumours
18 November 2024 - ALE.P02 is a first in class antibody-drug conjugate targeting CLDN1. ...
Posted by Michael Wonder on 12 Nov 2024
Genascence granted FDA fast track designation for GNSC-001 in patients with osteoarthritis of the knee
12 November 2024 - GNSC-001 is designed to offer long-term, sustained inhibition of IL-1 following a single injection into the affected ...
Posted by Michael Wonder on 05 Nov 2024
Electra Therapeutics receives FDA fast track designation for ELA026 in secondary haemophagocytic lymphohistiocytosis
4 November 2024 - Electra Therapeutics today announced that the US FDA has granted fast track designation for ELA026 for ...
Posted by Michael Wonder on 01 Nov 2024
FELIQS receives US FDA fast track designation for FLQ-101, a first in class small molecule to prevent retinopathy of prematurity
1 November 2024 - FELIQS announced today that the US FDA has granted its lead asset, FLQ-101, fast track designation for ...
Posted 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 ...