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RSS FeedPosted by Michael Wonder on 18 Feb 2025
Rznomics liver cancer drug candidate secures fast track designation
17 February 2025 - Second fast track designation following brain cancer approval. ...
Posted by Michael Wonder on 17 Feb 2025
Innovent receives second fast track designation from the US FDA for IBI363 (PD-1/IL-2α-bias bipspecific antibody fusion protein) in squamous non-small cell lung cancer
17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...
Posted by Michael Wonder on 13 Feb 2025
FDA grants fast track designation to PleoPharma's investigational new drug PP-01 for the mitigation of cannabis withdrawal symptoms in patients with cannabis use disorder: a potential first in class treatment
13 February 2025 - Phase 3 preparations underway. ...
Posted by Michael Wonder on 13 Feb 2025
NKGen Biotech receives US FDA fast track designation for troculeucel for the treatment of moderate Alzheimer’s disease
12 February 2025 - NKGen Biotech today announced that the US FDA has granted fast track designation for the investigation of ...
Posted by Michael Wonder on 12 Feb 2025
Lundbeck’s potential treatment amlenetug for multiple system atrophy receives fast track designation from the FDA
12 February 2025 - Lundbeck today announced that amlenetug has received fast track designation from the US FDA. ...
Posted by Michael Wonder on 12 Feb 2025
OnCusp Therapeutics receives FDA fast track designation for CUSP06 for the treatment of platinum-resistant ovarian cancer
12 February 2025 - OnCusp Therapeutics today announced that the US FDA has granted fast track designation to CUSP06, a cadherin-6 ...
Posted by Michael Wonder on 10 Feb 2025
Biodexa receives US FDA fast track designation for eRapa in familial adenomatous polyposis
10 February 2025 - Biodexa Pharmaceuticals announced today that the US FDA has granted fast track designation for eRapa, a proprietary ...
Posted by Michael Wonder on 10 Feb 2025
Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate to severe atopic dermatitis
10 February 2025 - Nektar Therapeutics today announced that the US FDA has granted fast track designation for rezpegaldesleukin for the ...
Posted 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 ...