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RSS FeedPosted by Michael Wonder on 17 Dec 2019
Kura Oncology receives fast track designation for tipifarnib in HRAS mutant HNSCC and provides enrolment guidance for AIM-HN trial
16 December 2019 - Registration-directed AIM-HN trial expected to complete enrolment in first quarter of 2021. ...
Posted by Michael Wonder on 17 Dec 2019
Salarius Pharmaceuticals receives FDA fast track designation for lead drug candidate, seclidemstat, in relapsed or refractory Ewing sarcoma
16 December 2019 - Phase 1/2 clinical study now underway; Salarius targeting key safety and efficacy data milestones in 2020. ...
Posted by Michael Wonder on 10 Dec 2019
Equillium granted U.S. FDA fast track designation for itolizumab for the treatment of lupus nephritis
9 December 2019 - Equillium today announced that the U.S. FDA has granted fast track designation for itolizumab for the ...
Posted by Michael Wonder on 10 Dec 2019
Dermira receives fast track designation from FDA for lebrikizumab for the treatment of atopic dermatitis
10 December 2019 - Dermira today announced that the U.S. FDA has granted fast track designation for lebrikizumab, its novel, investigational treatment ...
Posted by Michael Wonder on 10 Dec 2019
U.S. FDA grants VistaGen Therapeutics fast track designation for PH94B for treatment of social anxiety disorder
10 December 2019 - VistaGen's PH94B is the first drug candidate to be granted U.S. FDA fast track designation for treatment ...
Posted by Michael Wonder on 06 Dec 2019
Alector announces FDA fast track designation granted to AL001 for the treatment of patients with frontotemporal dementia
5 December 2019 - Alector today announced that the U.S. FDA has granted fast track designation for its investigational therapeutic, ...
Posted by Michael Wonder on 18 Nov 2019
Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome
18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) ...
Posted by Michael Wonder on 18 Nov 2019
Seelos Therapeutics receives FDA fast track designation for intranasal racemic ketamine (SLS-002)
18 November 2019 - Seelos Therapeutics today announced the U.S. FDA has granted fast track designation to its new, investigational intranasal ...
Posted by Michael Wonder on 13 Nov 2019
Viracta receives fast track designation for nanatinostat combination for the treatment of EBV-associated lymphomas
12 November 2019 - Viracta Therapeutic, announced today that the U.S. FDA has granted fast track designation for nanatinostat in ...
Posted by Michael Wonder on 09 Nov 2019
Triumvira Immunologics announces fast track designation for its first TAC T-Cell therapeutic product candidate: TAC01-CD19
7 November 2019 - Designation confirms significant unmet need remains in DLBCL. ...
Posted by Michael Wonder on 09 Nov 2019
EIP Pharma announces U.S. FDA grants fast-track designation to neflamapimod as a treatment for dementia with Lewy Bodies
7 November 2019 - EIP Pharma today announced that the Division of Neurology Products of the U.S. FDA has granted ...
Posted by Michael Wonder on 06 Nov 2019
Bionomics announces fast track designation granted by U.S. FDA to BNC210 development program for the treatment of PTSD
4 November 2019 - Bionomics announced today that the U.S. FDA has granted fast track designation to the BNC210 development program ...
Posted by Michael Wonder on 29 Oct 2019
Terns Pharmaceuticals receives fast track designation from the FDA for TERN-101, an FXR agonist for the treatment of NASH
29 October 2019 - Terns Pharmaceuticals today announced that TERN-101, an investigational farnesoid X receptor (FXR) agonist, has been granted fast ...
Posted by Michael Wonder on 28 Oct 2019
U.S. FDA grants fast track designation to Astellas for the development of ASP1128 for patients at risk for acute kidney injury
28 October 2019 - Astellas Pharma today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
Posted by Michael Wonder on 22 Oct 2019
Moderna receives FDA fast track designation for propionic acidemia program (mRNA-3927)
22 October 2019 - mRNA-3927 is Moderna’s second rare disease program to receive fast track designation. ...