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RSS FeedPosted by Michael Wonder on 22 Oct 2019
BerGenBio receives FDA approval of fast track designation for bemcentinib
22 October 2019 - BerGenBio today announces that the U.S FDA has approved fast track designation for bemcentinib for the treatment ...
Posted by Michael Wonder on 15 Oct 2019
Xenikos receives FDA fast track designation for T-Guard(R) for treating steroid-refractory acute graft-versus-host disease
14 October 2019 - Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial. ...
Posted by Michael Wonder on 10 Oct 2019
FDA grants FX-322 fast track designation
10 October 2019 - The company also announced today that the U.S. FDA has granted fast track designation for FX-322. ...
Posted by Michael Wonder on 07 Oct 2019
Mereo BioPharma receives FDA fast track designation for navicixizumab for the treatment of heavily pre-treated ovarian cancer
7 October 2019 - Mereo BioPharma today announces that the U.S. FDA has granted fast track designation to navicixizumab for the ...
Posted by Michael Wonder on 01 Oct 2019
Geron announces fast track designation granted to imetelstat for relapsed/refractory myelofibrosis
30 September 2019 - Geron Corporation today announced that the United States FDA has granted fast track designation to imetelstat for ...
Posted by Michael Wonder on 27 Sep 2019
Inventiva receives FDA fast track designation for lead asset lanifibranor in NASH
26 September 2019 - Designation is intended to facilitate the development and expedite the regulatory review of lanifibranor for the treatment ...
Posted by Michael Wonder on 24 Sep 2019
Aldeyra Therapeutics receives fast track designation for ADX-2191 for the prevention of proliferative vitreoretinopathy
24 September 2019 - Aldeyra Therapeutics today announced that the U.S. FDA has granted fast track designation to ADX-2191 for ...
Posted by Michael Wonder on 23 Sep 2019
Annexon Biosciences announces FDA fast track designation for novel C1q inhibitor ANX005 for the treatment of Guillain-Barré syndrome
23 September 2019 - Annexon plans to advance the clinical development of ANX005 for the treatment of GBS. ...
Posted by Michael Wonder on 23 Sep 2019
Xynomic Pharma receives fast track designation from the US FDA for abexinostat as fourth-line therapy treating follicular lymphoma
23 September 2019 - Xynomic Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to Xynomic’s lead ...
Posted 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 ...