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RSS FeedPosted by Michael Wonder on 04 Apr 2020
IVERIC bio announces fast track designation from U.S. FDA for Zimura for the treatment of geographic atrophy secondary to dry age-related macular degeneration
3 April 2020 - IVERIC bio announced today that the U.S. FDA has granted fast track designation to Zimura (avacincaptad ...
Posted by Michael Wonder on 01 Apr 2020
MEI Pharma announces fast track designation granted by U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma
31 March 2020 - MEI Pharma today announced that the U.S. FDA granted fast track designation to ME-401, MEI's investigational selective ...
Posted by Michael Wonder on 29 Mar 2020
Infinity receives fast track designation for IPI-549 in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer
25 March 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for IPI-549 in ...
Posted by Michael Wonder on 27 Mar 2020
IntraBio fast track designation for GM2 gangliosidosis
26 March 2020 - IntraBio is pleased to share that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 24 Mar 2020
Prevail Therapeutics receives U.S. FDA fast track designation for PR006 to slow the progression of frontotemporal dementia with a GRN mutation
24 March 2020 - Prevail Therapeutics today announced that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 19 Mar 2020
FDA to fast track clinical trials for coronavirus therapies
19 March 2020 - FDA Commissioner Stephen Hahn said the agency will test chloroquine, an anti-malarial drug, as a coronavirus treatment. ...
Posted by Michael Wonder on 18 Mar 2020
Biohaven's verdiperstat receives fast track designation for the treatment of multiple system atrophy
18 March 2020 - Biohaven Pharmaceutical announced today that the Company's myeloperoxidase inhibitor, verdiperstat, received Fast Track designation from the US ...
Posted by Michael Wonder on 13 Mar 2020
Agenus receives fast track designation for balstilimab & zalifrelimab in advanced cervical cancer
12 March 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab ...
Posted by Michael Wonder on 12 Mar 2020
US FDA grants fast track designation to Jardiance for the treatment of chronic kidney disease
12 March 2020 - FDA fast track designation is for the investigation of potential new therapies that treat serious conditions and ...
Posted by Michael Wonder on 11 Mar 2020
Daré Bioscience receives FDA fast track designation for DARE-BV1 for the treatment of bacterial vaginosis
10 March 2020 - DARE-BV1 demonstrated an 86% clinical cure rate in evaluable subjects at the test-of-cure visit after a single ...
Posted by Michael Wonder on 04 Mar 2020
Emerald Health Pharmaceuticals receives fast track designation from US FDA for EHP-101 in the treatment of systemic sclerosis
3 March 2020 - First-in-class product candidate in Phase 2 clinical development now has fast track and orphan designations. ...
Posted by Michael Wonder on 03 Mar 2020
Ayala Pharmaceuticals granted U.S. FDA fast track designation for AL101 for the treatment of recurrent or metastatic adenoid cystic carcinoma
3 March 2020 - Ayala Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to AL101 for ...
Posted by Michael Wonder on 25 Feb 2020
Lysogene receives FDA fast track designation for LYS-SAF302 gene therapy in MPS IIIA
25 February 2020 - 17th patient dosed in the ongoing phase 2/3 AAVance study. ...
Posted by Michael Wonder on 20 Feb 2020
FORMA Therapeutics announces FT-4202 granted fast track designation and rare paediatric disease designation for treatment of sickle cell disease
20 February 2020 - FORMA Therapeutics today announced the U.S. FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 18 Feb 2020
ALX Oncology’s ALX148 receives two fast track designations from FDA for the treatment of patients with head and neck squamous cell carcinoma and patients with gastric or gastro-esophageal junction adenocarcinoma
18 February 2020 - ALX Oncology today announced that the U.S. FDA has granted two fast track designations for its lead ...