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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →