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RSS FeedPosted by Michael Wonder on 11 Feb 2020
Nanobiotix announces fast track designation granted by U.S. FDA for investigation of first-in-class NBTXR3 in head and neck cancer
10 February 2020 - The U.S. FDA reviewed the Company’s request for fast track designation and concluded that investigation of NBTXR3 ...
Posted by Michael Wonder on 05 Feb 2020
Alector announces FDA fast track designation granted to AL101 for the treatment of patients with frontotemporal dementia
5 February 2020 - Alector today announced that the U.S. FDA has granted fast track designation to AL101 for the treatment ...
Posted by Michael Wonder on 05 Feb 2020
WPD Pharmaceuticals’ annamycin drug received FDA approval of fast track designation
5 February 2020 - WPD Pharmaceuticals is pleased to provide an update on its annamycin drug. ...
Posted by Michael Wonder on 04 Feb 2020
Anavex Life Sciences announces fast track designation granted by U.S. FDA for Anavex 2-73 (blarcamesine) clinical development program for the treatment of Rett syndrome
3 February 2020 - Anavex Life Sciences today announced that the U.S. FDA has granted fast track designation for Anavex 2-73 ...
Posted by Michael Wonder on 03 Feb 2020
Arrevus Receives FDA qualified infectious disease product designation for the treatment of cystic fibrosis pulmonary exacerbations
28 January 2020 - Arrevus today announced the U.S. FDA has granted qualified infectious disease product designation for ARV-1801 (sodium ...
Posted by Michael Wonder on 31 Jan 2020
Pulmatrix receives fast track designation for Pulmazole for the treatment of asthma-ABPA
30 January 2020 - Pulmatrix today announced that the U.S. FDA has granted fast track designation to PUR1900 (Pulmazole), the ...
Posted by Michael Wonder on 21 Jan 2020
Genprex receives U.S. FDA fast track designation for gene therapy that targets lung cancer
21 January 2020 - Genprex today announced that the U.S FDA has granted fast track Designation for Genprex’s Oncoprex immunogene ...
Posted 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 ...