Blog
RSS FeedPosted by Michael Wonder on 30 Mar 2022
Enanta Pharmaceuticals receives FDA fast track designation for EDP-235, its oral 3CL protease inhibitor specifically designed for the treatment and prevention of COVID-19
29 March 2022 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for EDP-235, its ...
Posted by Michael Wonder on 17 Mar 2022
Aquestive Therapeutics receives FDA fast track designation for AQST-109 for emergency treatment of allergic reactions including anaphylaxis
17 March 2022 - Aquestive Therapeutics today announced that the U.S. FDA has granted fast track designation to AQST-109, the first ...
Posted by Michael Wonder on 15 Mar 2022
Myrtelle receives FDA fast track, rare paediatric disease, and orphan drug designations for its proprietary gene therapy for the treatment of Canavan disease
15 March 2022 - Myrtelle today announced that the U.S. FDA has granted fast track, rare paediatric disease and orphan ...
Posted by Michael Wonder on 11 Mar 2022
Allogene Therapeutics receives FDA fast track designation for its first solid tumour candidate, ALLO-316 in the treatment of renal cell carcinoma
10 March 2022 - ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which has broad potential application across a ...
Posted by Michael Wonder on 09 Mar 2022
7 Hills Pharma’s clinical stage novel immunostimulant 7HP349 granted FDA fast track designation for anti-PD-1 resistant metastatic melanoma
8 March 2022 - 7 Hills Pharma announced today that the U.S. FDA has granted fast track designation to 7HP349, 7HP’s ...
Posted by Michael Wonder on 03 Mar 2022
U.S. Food and Drug Administration grants Cabaletta Bio fast track designation for MuSK-CAART
1 March 2022 - Fast Track Designation granted to improve activities of daily living and muscle strength in patients with ...
Posted by Michael Wonder on 03 Mar 2022
Harpoon Therapeutics receives FDA fast track designation for HPN217
2 March 2022 - Harpoon Therapeutics today announced that the U.S. FDA has granted fast track designation to HPN217, a BCMA ...
Posted by Michael Wonder on 22 Feb 2022
The truth about patient access and FDA fast tracking
21 February 2022 - University of Illinois Chicago researchers studied 135 products that received U.S. FDA approval through orphan drug and ...
Posted by Michael Wonder on 18 Feb 2022
OSE Immunotherapeutics is pleased to announce that Veloxis Pharmaceuticals, its partner in transplantation, has obtained FDA fast track designation for CD28 antagonist VEL-101/FR104
17 February 2022 - OSE Immunotherapeutics today announced that Veloxis Pharmaceuticals has obtained fast track designation from the U.S. FDA for ...
Posted by Michael Wonder on 18 Feb 2022
Immune-Onc Therapeutics receives FDA fast track designation for IO-202, the first anti-LILRB4 myeloid checkpoint inhibitor, for the treatment of relapsed or refractory acute myeloid leukaemia
17 February 2022 - Immune-Onc Therapeutics today announced that the U.S. FDA has granted fast track designation for IO-202, a first ...
Posted by Michael Wonder on 18 Feb 2022
Dizal Pharmaceutical receives U.S. FDA fast track designation for DZD4205 (golidocitinib) for the treatment of refractory or relapsed peripheral T-cell lymphoma
18 February 2022 - Fast track designation proves Dizal's world leading capability of developing potential first-in-class and much needed therapy to ...
Posted by Michael Wonder on 17 Feb 2022
FDA grants fast track designation to SBT101, the first investigational AAV based gene therapy for patients with adrenomyeloneuropathy
16 February 2022 - Initiation of Phase 1/2 clinical trial expected in the second half of 2022. ...
Posted by Michael Wonder on 16 Feb 2022
Poxel announces FDA fast track status for PXL065 in X linked adrenoleukodystrophy
16 February 2022 - The initiation of the Phase IIa proof of concept clinical study for PXL065 in adrenoleukodystrophy is now ...
Posted by Michael Wonder on 14 Feb 2022
Axcella Therapeutics announces FDA fast track designation for AXA1125 in NASH
14 February 2022 - EMMPACT Phase 2b clinical trial enrolling well, with interim data expected in mid 2022. ...
Posted by Michael Wonder on 10 Feb 2022
Bayer receives U.S. FDA fast track designation for asundexian stroke program
10 February 2022 - Bayer today announced that the U.S. FDA has granted fast track designation for its investigational drug ...