Blog
RSS FeedPosted by Michael Wonder on 20 Feb 2024
Medera’s Sardocor announces fast track designation and dosing of 3 patients in first in human HFpEF gene therapy trial
14 February 2024 - In the Phase 1/2A clinical trial for SRD-001, an adeno-associated virus mediated first in human gene therapy ...
Posted by Michael Wonder on 20 Feb 2024
Immuneering receives FDA fast track designation for IMM-1-104 in pancreatic cancer
20 February 2024 - Company expects multiple readouts from its Phase 1/2a clinical trial in 2024. ...
Posted by Michael Wonder on 20 Feb 2024
PepGen receives US FDA fast track designation for PGN-EDODM1 for the treatment of myotonic dystrophy type 1
20 February 2024 - PepGen today announced that the US FDA has granted fast track designation to PGN-EDODM1, an investigational candidate ...
Posted by Michael Wonder on 20 Feb 2024
Disc Medicine receives FDA fast track designation for DISC-0974 for the treatment of anaemia in non-dialysis dependent chronic kidney disease
20 February 2024 - Disc Medicine today announced that the US FDA has granted fast track designation to DISC-0974 for the ...
Posted by Michael Wonder on 19 Feb 2024
Certa Therapeutics’ FT011 granted US FDA fast track for the treatment of systemic sclerosis
19 February 2024 - Certa Therapeutics today announces that the US FDA has granted fast track designation for its investigational therapy ...
Posted by Michael Wonder on 16 Feb 2024
Caliway received US FDA fast track designation for CBL-514 for the treatment of Dercum's disease
14 February 2024 - CBL-514 is the first drug to receive fast track designation for Dercum's disease treatment. ...
Posted by Michael Wonder on 15 Feb 2024
Diamyd Medical receives US FDA fast track designation for Diamyd
15 February 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) that ...
Posted by Michael Wonder on 13 Feb 2024
CAN-3110 receives FDA fast track designation for treatment of recurrent high-grade glioma
13 February 2024 - Candel Therapeutics today announced that the US FDA granted fast track designation for CAN-3110 -- a first ...
Posted by Michael Wonder on 13 Feb 2024
Edgewise receives US FDA fast track designation for EDG-5506 for the treatment of Duchenne muscular dystrophy
13 February 2024 - Edgewise Therapeutics today announced that the US FDA has granted fast track designation for EDG-5506 for the ...
Posted by Michael Wonder on 12 Feb 2024
BioXcel Therapeutics receives FDA fast track designation for BXCL701 for treatment of small cell neuroendocrine prostate cancer
12 February 2024 - BXCL701 is an investigational, oral innate immune activator designed to inflame the tumour microenvironment and augment CPI ...
Posted by Michael Wonder on 12 Feb 2024
GSK receives US FDA fast track designation for bepirovirsen in chronic hepatitis B
12 February 2024 - Designation underscores the unmet need for medicines that can achieve functional cure in patients with chronic ...
Posted by Michael Wonder on 08 Feb 2024
Eplontersen granted US FDA fast track designation for patients with transthyretin-mediated amyloid cardiomyopathy
8 February 2024 - Ionis Pharmaceuticals announced today that the US FDA has granted fast track designation to Ionis and ...
Posted by Michael Wonder on 06 Feb 2024
Arvinas and Pfizer’s vepdegestrant (ARV-471) receives FDA fast track designation for the treatment of patients with ER positive/HER2 negative metastatic breast cancer
6 February 2024 - Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC) protein degrader designed to target and degrade the ...
Posted by Michael Wonder on 05 Feb 2024
Ultimovacs receives FDA fast track designation for UV1 cancer vaccine for the treatment of patients with unresectable mesothelioma
5 February 2024 - The designation was granted by the US FDA based on results from the randomised Phase II clinical ...
Posted by Michael Wonder on 01 Feb 2024
Biosyngen announces FDA fast track designation for BST02 in treatment of liver cancer
1 February 2024 - Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted fast track designation ...