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RSS FeedPosted by Michael Wonder on 26 Apr 2022
Treadwell Therapeutics announces fast track designation granted by the FDA to CFI-400945 for the treatment of acute myeloid leukaemia
26 April 2022 - Treadwell Therapeutics announced today that the U.S. FDA has granted fast track designation to CFI-400945, a first ...
Posted by Michael Wonder on 20 Apr 2022
FDA granted CMG901 fast track designation for unresectable or metastatic gastric and gastro-oesophageal junction cancer which have relapsed and/or are refractory to approved therapies
19 April 2022 - Keymed Biosciences announced that the U.S. FDA granted CMG901 fast track designation as monotherapy for the ...
Posted by Michael Wonder on 19 Apr 2022
Innovative Cellular Therapeutics receives FDA fast track designation for GCC19CART, its lead solid tumour candidate, in the treatment of patients with relapsed or refractory metastatic colorectal cancer
19 April 2022 - GCC19CART is an autologous CAR T therapy candidate that has shown promising results in over 30 relapsed ...
Posted by Michael Wonder on 19 Apr 2022
Aytu BioPharma announces fast track designation granted to AR101 for the treatment of vascular Ehlers-Danlos syndrome
19 April 2022 - Aytu BioPharma today announced that the U.S. FDA has granted fast track designation to AR101 (enzastaurin), a ...
Posted by Michael Wonder on 19 Apr 2022
Adicet Bio receives FDA fast track designation for lead candidate ADI-001
19 April 2022 - Adicet Bio today announced the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 13 Apr 2022
BriaCell receives FDA fast track approval for targeted breast cancer immunotherapy
13 April 2022 BriaCell is currently enrolling and dosing advanced breast cancer patients in a Phase I/IIa study, now with ...
Posted by Michael Wonder on 12 Apr 2022
US FDA grants fast track designation for Paradigm’s Phase 3 osteoarthritis program
12 April 2022 - Paradigm Biopharmaceuticals is pleased to announce that the U.S. FDA has granted fast track designation for ...
Posted by Michael Wonder on 12 Apr 2022
Recursion is granted fast track designation for REC-4881 for the potential treatment of familial adenomatous polyposis
11 April 2022 - Recursion today announced that the U.S. FDA has granted the company fast track designation for REC-4881 ...
Posted by Michael Wonder on 11 Apr 2022
Poxel announces PXL770 awarded FDA fast track designation for X-linked adrenoleukodystrophy
11 April 2022 - Poxel is pleased to announce that the U.S. FDA has granted fast track designation to PXL770 ...
Posted by Michael Wonder on 06 Apr 2022
Dialectic Therapeutics announces DT2216 has received fast track designation from the FDA for adult patients with relapsed or refractory peripheral and cutaneous T-cell lymphoma
5 April 2022 - Dialectic Therapeutics today announced that the U.S. FDA has granted fast track designation to DT2216 for adult ...
Posted by Michael Wonder on 04 Apr 2022
Precigen receives fast track designation for PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukaemia
4 April 2022 - PRGN-3006 UltraCAR-T previously received orphan drug designation in patients with acute myeloid leukaemia by the US FDA. ...
Posted by Michael Wonder on 02 Apr 2022
DT-216 granted FDA fast track designation for patients with Friedreich's ataxia
30 March 2022 - DT-216 is a novel GeneTAC gene targeted chimera small molecule designed to specifically target the GAA repeat ...
Posted by Michael Wonder on 31 Mar 2022
ASC Therapeutics receives key regulatory designations in U.S. and Europe to advance its second generation gene therapy for haemophilia A
29 March 2022 - ASC Therapeutics has received from the U.S. FDA the fast track designation for ASC618, a second-generation gene ...
Posted 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 ...