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RSS FeedPosted by Michael Wonder on 27 Jun 2024
Carisma Therapeutics granted FDA fast track designation for CT-0525 for the treatment of HER2 overexpressing solid tumours
25 June 2024 - Initial Phase 1 data expected by year end 2024. ...
Posted by Michael Wonder on 25 Jun 2024
Oncoinvent receives FDA fast track designation for Radspherin as treatment for peritoneal carcinomatosis from ovarian cancer
24 June 2024 - Phase 2b trial of Radspherin to treat ovarian cancer patients expected to initiate imminently. ...
Posted by Michael Wonder on 25 Jun 2024
BioNTech and DualityBio receive FDA fast track designation for antibody-drug conjugate candidate BNT324/DB-1311 in prostate cancer
24 June 2024 - Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with ...
Posted by Michael Wonder on 13 Jun 2024
Innovent receives fast track designation from the US FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
12 June 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its TOPO1i anti-CLDN18.2 ADC ...
Posted by Michael Wonder on 10 Jun 2024
FDA grants fast track designation to GCBP and Novel Pharma's GC1130A
10 June 2024 - GC Biopharma and Novel Pharma have announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 10 Jun 2024
SpliSense receives FDA fast track designation for SPL84 for the treatment of cystic fibrosis
29 May 2024 - SpliSense today announced that the US FDA has granted fast track designation to SPL84 for cystic ...
Posted by Michael Wonder on 05 Jun 2024
Adicet Bio receives FDA fast track designation for ADI-001 in lupus nephritis
5 June 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the potential ...
Posted by Michael Wonder on 05 Jun 2024
Quince Therapeutics receives US FDA fast track designation for EryDex system
3 June 2024 - Quince Therapeutics today announced that the US FDA has granted fast track designation for its EryDex System ...
Posted by Michael Wonder on 04 Jun 2024
Repare Therapeutics announces fast track designation granted by the FDA for lunresertib in combination with camonsertib for the treatment of platinum resistant ovarian cancer
4 June 2024 - Repare Therapeutics today announced the US FDA has granted fast track designation to lunresertib in combination with ...
Posted 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 ...