Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2024
Ellipses' next generation selective RET inhibitor EP0031/A400 granted fast track designation by US FDA
5 March 2024 - Ellipses Pharma announced today that it has received fast track designation from the US FDA for its ...
Posted by Michael Wonder on 29 Feb 2024
Indapta Therapeutics receives US FDA fast track designation for lead clinical drug candidate IDP-023 for non-Hodgkin’s lymphoma and myeloma
29 February 2024 - Highly differentiated allogeneic natural killer cell therapy in Phase 1 trial, with initial data expected in second ...
Posted by Michael Wonder on 28 Feb 2024
FDA grants fast track designation to 9MW2821
27 February 2024 - Mabwell announces that its self developed novel antibody drug conjugate targeting Nectin-4 (9MW2821) has been granted fast ...
Posted by Michael Wonder on 22 Feb 2024
Artiva Biotherapeutics receives FDA fast track designation for AlloNK in lupus nephritis
22 February 2024 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to Artiva’s lead ...
Posted by Michael Wonder on 20 Feb 2024
Omnix Medical granted fast track designation by US FDA for its next generation anti-infective OMN6
20 February 2024 - Omnix Medical today announced that the Company has received fast track designation for its novel anti-infective ...
Posted 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 ...