Blog
RSS FeedPosted by Michael Wonder on 06 Dec 2024
Sana Biotechnology announces fast track designation for SC291 in relapsed/refractory systemic lupus erythematosus
2 December 2025 - Enrolling patients in the GLEAM trial for SC291 in B-cell mediated auto-immune diseases, including systemic lupus erythematosus; ...
Posted by Michael Wonder on 05 Dec 2024
Lin BioScience receives US FDA fast track designation for LBS-007
27 November 2024 - A Phase 1/2 trial in patients with relapsed or resistant acute leukaemias is on-going. ...
Posted by Michael Wonder on 19 Nov 2024
Alkeus Pharmaceuticals receives FDA rare paediatric disease and fast track designations for gildeuretinol as a treatment for Stargardt disease
18 November 2024 - Alkeus Pharmaceuticals today announced that gildeuretinol (ALK-001), an investigational oral therapy, has received rare paediatric disease and ...
Posted 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. ...