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RSS FeedPosted by Michael Wonder on 12 Jul 2023
Biosyngen's first in class cell therapy BRG01 receives FDA fast track designation
12 July 2023 - On July 6, 2023, Biosyngen received an official notification from the US FDA granting fast track ...
Posted by Michael Wonder on 11 Jul 2023
Synlogic granted fast track designation from FDA for labafenogene marselecobac (SYNB1934) for treatment of phenylketonuria
11 July 2023 - Synlogic today announced that the US FDA has granted fast track designation to labafenogene marselecobac (previously known ...
Posted by Michael Wonder on 06 Jul 2023
Kazia's paxalisib receives fast track designation from FDA for treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy
6 July 2023 - Kazia Therapeutics is pleased to announce that its lead program, paxalisib, has been awarded fast track ...
Posted by Michael Wonder on 29 Jun 2023
Genprex receives US FDA fast track designation for Reqorsa immunogene therapy in combination with Tecentriq for the treatment of small cell lung cancer
28 June 2023 - Third FDA fast track designation further validates the potential of Reqorsa. ...
Posted by Michael Wonder on 27 Jun 2023
AC Immune receives FDA fast track designation for anti-amyloid beta active immunotherapy, ACI-24.060, to treat Alzheimer’s disease
27 June 2023 - Initial PET data on amyloid plaque reduction in Alzheimer's disease expected H1, 2024. ...
Posted by Michael Wonder on 27 Jun 2023
GSK receives US FDA fast track designation for investigational vaccine against gonorrhoea
27 June 2023 - Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to ...
Posted by Michael Wonder on 22 Jun 2023
Cidara Therapeutics receives US FDA fast track designation for CD388, a novel drug-FC conjugate targeting influenza A and B
22 June 2023 - Cidara Therapeutics today announced that the US FDA has granted fast track designation to CD388, Cidara’s novel ...
Posted by Michael Wonder on 21 Jun 2023
Teikoku Pharma granted FDA fast track designation for TPU-006, a novel 4 day dexmedetomidine transdermal system for post operative pain management
21 June 2023 - Teikoku Pharma today announced that the US FDA granted fast track designation for TPU-006 in managing post-operative ...
Posted by Michael Wonder on 14 Jun 2023
CellCentric receives FDA fast track designation for relapsed refractory multiple myeloma drug
13 June 2023 - CellCentric has announced that the US FDA has granted its novel cancer drug, inobrodib, fast track designation ...
Posted by Michael Wonder on 13 Jun 2023
Eupraxia Pharmaceuticals receives US FDA fast track designation for EP-104IAR in treatment of osteoarthritis
13 June 2023 - Eupraxia Pharmaceuticals today announced that the US FDA has granted fast track designation for the investigation of ...
Posted by Michael Wonder on 08 Jun 2023
Rocket Pharmaceuticals receives FDA fast track and orphan drug designations for RP-A601 gene therapy for PKP2 arrhythmogenic cardiomyopathy
8 June 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted fast track and orphan drug designations ...
Posted by Michael Wonder on 08 Jun 2023
SAR443579/IPH6101 receives FDA fast track designation in the US for the treatment of haematological malignancies
8 June 2023 - SAR443579, ANKET platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research ...
Posted by Michael Wonder on 01 Jun 2023
Arcturus Therapeutics receives US FDA fast track designation for ARCT-810, mRNA therapeutic candidate for ornithine transcarbamylase deficiency
1 June 2023 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation to ARCT-810, the Company’s ...
Posted by Michael Wonder on 30 May 2023
Inhibrx granted fast track designation for INBRX-101 for the treatment of alfa-1 antitrypsin deficiency
30 May 2023 - Inhibrx announced today that the US FDA granted fast track designation to INBRX-101, an optimised recombinant ...
Posted by Michael Wonder on 25 May 2023
Milvexian granted US FDA fast track designation for all three indications under evaluation in Phase 3 Librexia program: ischaemic stroke, acute coronary syndrome and atrial fibrillation
25 May 2023 - The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development ...