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RSS FeedPosted by Michael Wonder on 10 Feb 2025
Tempest granted fast track designation from the US FDA for amezalpat to treat patients with hepatocellular carcinoma
10 January 2025 - Tempest Therapeutics today announced that the US FDA has granted fast track designation to amezalpat (TPST-1120), an ...
Posted by Michael Wonder on 06 Feb 2025
Bracco Imaging receives FDA fast track designation for BR55, ultrasound molecular imaging agent for the detection of active bowel inflammation in Crohn's disease
6 February 2025 - BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the ...
Posted by Michael Wonder on 05 Feb 2025
Adicet Bio receives FDA fast track designation for ADI-001 for the treatment of refractory systemic lupus erythematosus with extra-renal involvement
5 February 2025 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the ...
Posted by Michael Wonder on 29 Jan 2025
FDA grants Vicore’s buloxibutid fast track designation for idiopathic pulmonary fibrosis
29 January 2025 - Vicore Pharma today announced that the US FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 24 Jan 2025
Clarity receives US FDA fast track designation for Cu 64 SAR-bisPSMA in biochemical recurrence of prostate cancer
24 January 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 22 Jan 2025
Nacuity Pharmaceuticals granted US FDA fast track designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
21 January 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted fast track designation to NPI-001 (N-acetylcysteine amide) ...
Posted by Michael Wonder on 21 Jan 2025
Dyne Therapeutics receives FDA fast track designation for DYNE-101 for the treatment of myotonic dystrophy type 1
21 January 2025 - Dyne Therapeutics today announced that the US FDA has granted fast track designation for DYNE-101 for ...
Posted by Michael Wonder on 21 Jan 2025
Solid Biosciences receives FDA fast track designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
21 January 2025 - Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and ...
Posted by Michael Wonder on 21 Jan 2025
Life Molecular Imaging secures FDA fast track designation for [18F] florbetaben in diagnosing cardiac AL and ATTR amyloidosis
21 January 2025 - [18F] florbetaben has been granted a fast track designation for cardiac amyloidosis, which will expedite the development ...
Posted by Michael Wonder on 14 Jan 2025
Lokon Pharma receives FDA fast track designation for LOAd703 for the treatment of pancreatic cancer
10 January 2025 - Lokon Pharma today announced that the US FDA has granted fast track designation for the company´s product ...
Posted by Michael Wonder on 13 Jan 2025
FDA grants fast track designation to Spinogenix's SPG601 for treatment of Fragile X syndrome, a common inherited form of autism
13 January 2025 - -- Spinogenix today announced that the US FDA has granted fast track designation to SPG601 for the ...
Posted by Michael Wonder on 12 Jan 2025
BridgeBio Oncology Therapeutics granted US FDA fast track designation for BBO-8520 for KRASG12C mutated metastatic non-small cell lung cancer
9 January 2025 - The US FDA has granted fast track designation to BBO-8520 for the treatment of adult patients with ...
Posted by Michael Wonder on 12 Jan 2025
Mersana Therapeutics announces additional FDA fast track designation granted to emiltatug ledadotin (XMT-1660)
10 January 2025 - Mersana Therapeutics today announced the US FDA recently granted an additional fast track designation to XMT-1660. ...
Posted by Michael Wonder on 09 Jan 2025
PureTech receives FDA fast track designation for LYT-200 in acute myeloid leukaemia
9 January 2024 - Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of ...
Posted by Michael Wonder on 09 Jan 2025
Marengo’s first in class invikafusp alfa (STAR0602) receives US FDA fast track designation for treatment of unresectable, locally advanced, or metastatic colorectal cancers with high tumour mutational burden
8 January 2025 - Initial safety and efficacy data from Phase 1 STARt-001 trial showed promising single agent clinical activity ...