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RSS FeedPosted by Michael Wonder on 16 Jan 2020
FDA grants fast track designation to Arena Pharmaceuticals' APD418 for development in decompensated heart failure patients
16 January 2020 - Arena Pharmaceuticals today announced that the U.S. FDA granted fast track designation for APD418, a β3-adrenergic ...
Posted by Michael Wonder on 16 Jan 2020
Novavax granted fast track designation for NanoFlu in older adults
15 January 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NanoFlu, its recombinant quadrivalent ...
Posted by Michael Wonder on 13 Jan 2020
Imago receives fast track designation from U.S. FDA for bomedemstat for treatment of essential thrombocythemia
13 January 2020 - Imago BioScience today announced that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 10 Jan 2020
Meissa Vaccines receives U.S. FDA fast track designation for respiratory syncytial virus vaccine, MV-012-968
10 January 2020 - Meissa Vaccines announced today that the U.S. FDA has granted fast track designation to MV-012-968, an ...
Posted by Michael Wonder on 09 Jan 2020
Minoryx Therapeutics receives US FDA fast-track designation for leriglitazone in the treatment of X-ALD
9 January 2020 - Leriglitazone (MIN-102), a novel, brain penetrant, orally bioavailable and selective PPARγ agonist, is currently in late-stage development ...
Posted by Michael Wonder on 08 Jan 2020
ReNetX Bio receives fast track designation from U.S. FDA
8 January 2020 - Potential first-in-class therapy for chronic spinal cord injury. ...
Posted by Michael Wonder on 06 Jan 2020
BridgeBio Pharma’s QED Therapeutics receives fast track designation for infigratinib in adults with first-line advanced or metastatic cholangiocarcinoma and orphan drug designation for infigratinib for treatment of cholangiocarcinoma
6 January 2020 - The PROOF trial, a Phase 3 trial of infigratinib in first-line cholangiocarcinoma, is currently enrolling. ...
Posted by Michael Wonder on 18 Dec 2019
Orphazyme’s arimoclomol receives US fast track designation in sporadic inclusion body myositis
18 December 2019 - Orphazyme today received fast track designation from the US FDA for the development of arimoclomol for the ...
Posted 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) ...