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RSS FeedPosted by Michael Wonder on 18 Apr 2024
AskBio receives FDA fast track designation for AB-1002 investigational gene therapy program in congestive heart failure
18 April 2024 - AB-1002 is being studied for the treatment of adults with non-ischaemic cardiomyopathy and New York Heart Association ...
Posted by Michael Wonder on 16 Apr 2024
Lexeo Therapeutics granted FDA fast track designation for LX2006, an AAV based gene therapy candidate for the treatment of Friedreich’s ataxia cardiomyopathy
16 April 2024 - Lexeo Therapeutics today announced the US FDA has granted fast track designation to LX2006, the company’s AAVrh.10hFXN ...
Posted by Michael Wonder on 16 Apr 2024
TLX101-CDx (Pixclara) granted FDA fast track designation
16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational ...
Posted by Michael Wonder on 11 Apr 2024
PureTech receives FDA fast track designation for LYT-200 in head and neck cancers
11 April 2024 - LYT-200 is being evaluated in locally advanced/metastatic solid tumours, including head and neck cancers, as well as ...
Posted by Michael Wonder on 10 Apr 2024
AdrenoMed receives FDA fast track designation for enibarcimab for treatment of septic shock
10 April 2024 - AdrenoMed today announced that the US FDA has granted fast track designation to its lead product candidate ...
Posted by Michael Wonder on 09 Apr 2024
Syros receives fast track designation from the FDA for tamibarotene for the treatment of newly diagnosed unfit AML with RARA gene over-expression
9 April 2024 - Syros Pharmaceuticals today announced that the US FDA has granted fast track designation to tamibarotene in ...
Posted by Michael Wonder on 08 Apr 2024
Phanes Therapeutics' PT217 granted fast track designation by the FDA
8 April 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT217 for the ...
Posted by Michael Wonder on 03 Apr 2024
RemeGen's telitacicept (RC18) granted fast track designation by US FDA for treatment of primary Sjögren's syndrome
2 April 2024 - RemeGen has obtained fast track designation by the US FDA recently for its innovative BLyS/APRIL dual-target ...
Posted by Michael Wonder on 02 Apr 2024
TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer
2 April 2024 - Fast track designation for NOX-A12 follows recently announced FDA clearance of investigational new drug application for Phase ...
Posted by Michael Wonder on 29 Mar 2024
LISCure Biosciences receives US FDA fast track designation for LB-P8 for the treatment of primary sclerosing cholangitis
29 March 2024 - Phase 2 study is underway and LB-P8 is the only live biotherapeutic product currently reported to be ...
Posted by Michael Wonder on 29 Mar 2024
Korean drug for metabolism-related steatohepatitis gets FDA’s fast track designation
28 March 2024 - D&D Pharmatech said Thursday that DD01, an injectable treatment for metabolic-associated steatohepatitis (MASH) being developed by ...
Posted by Michael Wonder on 26 Mar 2024
Johnson & Johnson's nipocalimab granted US FDA fast track designation to reduce the risk of foetal neonatal allo-immune thrombocytopenia in allo-immunised pregnant adults
26 March 2024 - The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported ...
Posted by Michael Wonder on 16 Mar 2024
ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment
15 March 2024 - ImmVira has recently announced that the US FDA has granted fast track designation for oncolytic virus product ...
Posted by Michael Wonder on 14 Mar 2024
Keros Therapeutics announces US FDA fast track designation for KER-050 in lower-risk myelodysplastic syndromes
14 March 2024 - Keros Therapeutics today announced that the US FDA has granted fast track designation for KER-050 (elritercept) for ...
Posted by Michael Wonder on 06 Mar 2024
Trellis Bioscience's TRL1068 receives FDA fast track and QIDP designations, amplifying commitment to combat infectious diseases
6 March 2024 - Trellis Bioscience is thrilled to announce that its lead antibody candidate, TRL1068, has been granted fast ...