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RSS FeedPosted by Michael Wonder on 19 Sep 2019
FDA grants fast track designation for SPI-1005 in the treatment of Meniere's disease
18 September 2019 - Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request ...
Posted by Michael Wonder on 16 Sep 2019
Wave Life Sciences announces fast track designation from U.S. FDA for suvodirsen
16 September 2019 - Suvodirsen is an investigational stereopure oligonucleotide in development for the treatment of DMD patients amenable to exon ...
Posted by Michael Wonder on 16 Sep 2019
FDA grants fast track designation for Farxiga in heart failure
16 September 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 10 Sep 2019
ProQR receives fast track designation from FDA for QR-1123 for autosomal dominant retinitis pigmentosa
9 September 2019 - ProQR Therapeutics today announced that it received fast track designation from the FDA for QR-1123. ...
Posted by Michael Wonder on 10 Sep 2019
FDA grants fast track status to Amplyx Pharmaceuticals for IV and oral formulations of fosmanogepix (APX001) for seven different indications
9 September 2019 - -- Amplyx Pharmaceuticals announced today that the U.S. FDA has granted fast track designations for both ...
Posted by Michael Wonder on 09 Sep 2019
FDA grants AMG 510 fast track designation for previously treated metastatic NSCLC with KRAS G12C mutation
8 September 2019 - Amgen today announced new data from the ongoing Phase 1 study evaluating AMG 510 in patients with ...
Posted by Michael Wonder on 04 Sep 2019
Forty Seven granted fast track designation for magrolimab for the treatment of myelodysplastic syndrome and acute myeloid leukaemia
3 September 2019 - Forty Seven today announced that the U.S. FDA has granted fast track designation to magrolimab (formerly known ...
Posted by Michael Wonder on 04 Sep 2019
Inotrem announces fast track designation granted by U.S. FDA to nangibotide development program for the treatment of septic shock
4 September 2019 - Inotrem announced today that the U.S. FDA has granted fast track designation to nangibotide development program for ...
Posted by Michael Wonder on 29 Aug 2019
Zensun announces the investigation of Neucardin for chronic heart failure receives fast track designation from the US FDA
26 August 2019 - Zensun announced that the investigation of Neucardin, its recombinant human neuregulin-1 fragment, has received fast track designation ...
Posted by Michael Wonder on 29 Aug 2019
Emalex Biosciences receives FDA fast track designation for ecopipam for the treatment of patients with Tourette syndrome
28 August 2019 - Emalex Biosciences announced today that it has received fast track designation for its investigational product, ecopipam, from ...
Posted by Michael Wonder on 27 Aug 2019
DiscGenics receives FDA fast track designation for disc degeneration cell therapy
26 August 2019 - DiscGenics today announced that the U.S. FDA has granted Fast Track designation for its investigational cell ...
Posted by Michael Wonder on 27 Aug 2019
FDA grants fast track designation for Farxiga in chronic kidney disease
27 August 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 25 Aug 2019
Medipost’s Pneumostem gets FDA’s fast-track designation
23 August 2019 - Medipost said that the U.S. FDA has given a fast- track designation for Pneumostem, a bronchopulmonary ...
Posted by Michael Wonder on 21 Aug 2019
Cerecor receives fast track designation from FDA for CERC-802 for the treatment of mannose-phosphate isomerase deficiency
21 August 2019 - Cerecor announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ...
Posted by Michael Wonder on 20 Aug 2019
Moderna receives FDA fast track designation for Zika vaccine mRNA-1893
19 August 2019 - Moderna today announced that the U.S. FDA has granted fast track designation for its investigational Zika vaccine ...