Blog
RSS FeedPosted by Michael Wonder on 31 May 2024
NH TherAguix receives FDA fast track designation for AGuIX, its novel radio-enhancer in the treatment of malignant gliomas, and provides an update on its developments and prospects
30 May 2024 - Key regulatory milestone confirming the interest of the US authorities in AGuIX, a next generation nanodrug ...
Posted by Michael Wonder on 30 May 2024
Affimed receives fast track designation for combination therapy of AFM24 with atezolizumab for EGFR wild type non-small cell lung cancer
29 May 2024 - The FDA’s fast track designation was granted after its review of the initial efficacy data of the ...
Posted by Michael Wonder on 28 May 2024
Vasomune Therapeutics receives US FDA fast track designation for novel investigational medicine AV-001
28 May 2024 - Vasomune Therapeutics has announced today that the US FDA granted fast track designation for AV-001 for the ...
Posted by Michael Wonder on 25 May 2024
Sobi receives US FDA fast track designation for emapalumab-lzsg being investigated in macrophage activation syndrome
24 May 2024 - Sobi North America today announced that the US FDA has granted fast track designation to emapalumab-lzsg being ...
Posted by Michael Wonder on 23 May 2024
Theriva Biologics announces fast track designation granted by the US FDA for VCN-01 for the treatment of metastatic pancreatic cancer
23 May 2024 - Theriva Biologics today announced that the US FDA has granted fast track designation to lead clinical candidate ...
Posted by Michael Wonder on 21 May 2024
Ractigen Therapeutics secures FDA fast track designation for RAG-01, a first in class saRNA therapy
21 May 2024 - Ractigen Therapeutics proudly announces that its flagship program, RAG-01, has been granted fast track designation by ...
Posted by Michael Wonder on 21 May 2024
Transposon receives US FDA fast track designation for TPN-101 for progressive supranuclear palsy
21 May 2024 - TPN-101 is the first PSP treatment to reduce NfL and IL-6 levels, key biomarkers of neurodegeneration ...
Posted by Michael Wonder on 20 May 2024
Aprinoia Therapeutics announces fast track designation granted by US FDA to APN-1607 (florzolotau) for the diagnosis of progressive supranuclear palsy
20 May 2024 - Aprinoia Therapeutics today announced that on 8 May 2024, the US FDA granted fast track designation to ...
Posted 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 ...