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RSS FeedPosted by Michael Wonder on 10 May 2024
SN Bioscience receives FDA fast track designation for small cell lung cancer
9 May 2024 - SN Bioscience announced on 7 May that the FDA has granted fast track designation for small cell ...
Posted by Michael Wonder on 08 May 2024
Avidity Biosciences receives FDA breakthrough therapy designation for delpacibart etedesiran (AOC 1001) for treatment of myotonic dystrophy type 1
8 May 2024 - Delpacibart etedesiran data from MARINA-OLE showed reversal of disease progression in multiple functional measures in DM1 ...
Posted by Michael Wonder on 07 May 2024
iECURE receives FDA fast track designation for ECUR-506 for the treatment of neonatal onset ornithine transcarbamylase deficiency
6 May 2024 - iECURE announced today that it has received fast track designation from the US FDA for ECUR-506, ...
Posted by Michael Wonder on 06 May 2024
MannKind receives US FDA fast track designation for clofazimine inhalation suspension for the treatment of non-tuberculous mycobacterial lung disease
6 May 2024 - MannKind Corporation announced today that the US FDA has granted fast track designation of clofazimine inhalation suspension ...
Posted by Michael Wonder on 02 May 2024
Amolyt Pharma granted FDA fast track designation for eneboparatide for the treatment of hypoparathyroidism
2 May 2024 - Amolyt Pharma today announced that eneboparatide, its lead therapeutic peptide candidate in Phase 3 development for the ...
Posted by Michael Wonder on 25 Apr 2024
Compass Therapeutics receives FDA fast track designation for the investigation of CTX-009 in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract tumours that have been previously treated
25 April 2024 - Compass Therapeutics today announced that the US FDA has granted fast track designation to CTX-009, the Company’s ...
Posted by Michael Wonder on 25 Apr 2024
Deverra Therapeutics granted FDA fast track designation for DVX101 (dilanubicel) for the treatment of acute myeloid leukaemia
24 April 2024 - Deverra Therapeutics today announced that the US FDA granted fast track designation to dilanubicel, the Company's ...
Posted by Michael Wonder on 23 Apr 2024
Medicure receives US FDA fast track designation for MC-1 for PNPO deficiency
23 April 2024 - Medicure announced today that through its subsidiary, Medicure International, the US FDA has granted fast track designation ...
Posted 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 ...