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RSS FeedPosted by Michael Wonder on 17 Nov 2025
FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer
17 November 2025 - Dewpoint Therapeutics announced today that the US FDA has granted fast track designation to DPTX3186, the company’s ...
Posted by Michael Wonder on 14 Nov 2025
Allterum Therapeutics receives FDA fast track designation for 4A10 in acute lymphoblastic leukaemia
11 November 2025 - Allterum Therapeutics today announced that the US FDA has granted fast track designation for its lead program, ...
Posted by Michael Wonder on 12 Nov 2025
Parabilis Medicines receives FDA fast track designation for FOG-001, the first and only direct inhibitor of the β-catenin:TCF interaction for the treatment of desmoid tumours
12 November 2025 - Parabilis Medicines today announced that the US FDA has granted fast track product designation to FOG-001 ...
Posted by Michael Wonder on 12 Nov 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
Posted by Michael Wonder on 10 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best in class EGFR/HER3 bispecific antibody drug conjugate, for the treatment of patients with EGFR mutated TKI pretreated NSCLC
10 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-1418 (DB-1418), a potential ...
Posted by Michael Wonder on 04 Nov 2025
Benitec Biopharma receives FDA fast track designation for BB-301
3 November 2025 - Benitec Biopharma today provides positive interim clinical results for the BB-301 Phase 1b/2a clinical trial. ...
Posted by Michael Wonder on 29 Oct 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
28 October 2025 - Alphamab Oncology announced that the biparatopic HER2-targeting antibody drug conjugate JSKN003 has been granted fast track designation ...
Posted by Michael Wonder on 25 Oct 2025
Agitated Solutions receives fast track designation for investigational drug ASI-02
23 October 2025 - ASI-02 is a novel contrast agent for cardiac bubble studies. ...
Posted by Michael Wonder on 23 Oct 2025
Heidelberg Pharma’s lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma
23 October 2025 - Heidelberg Pharma today announced that HDP-101 (pamlectabart tismanitin), the Company’s lead amanitin-based ADC candidate, has been ...
Posted by Michael Wonder on 23 Oct 2025
FDA grants fast track designation for AJ201, a first in class therapy for Kennedy's disease
23 October 2025 - AnnJi Pharmaceutical today announced that the US FDA has granted fast track designation for AJ201, the first ...
Posted by Michael Wonder on 22 Oct 2025
Myosin Therapeutics receives FDA fast track designation for MT-125 in glioblastoma
22 October 2025 - Myosin Therapeutics today announced that the US FDA has granted fast track designation to MT-125 for the ...
Posted by Michael Wonder on 22 Oct 2025
GondolaBio receives US FDA orphan drug and fast track designations for PORT-77 for the treatment of erythropoietic protoporphyria and X-linked protoporphyria
21 October 2025 - PORT-77 is currently being investigated in the Phase 2A proof of concept trial, GATEWAY, with the primary ...
Posted by Michael Wonder on 22 Oct 2025
Immusoft receives FDA fast track designation for ISP-001, a first in class engineered B-cell therapy for MPS I
21 October 2025 - Prospectively designed for scalability and re-dosability, Immusoft's engineered B cells represent the next generation of advanced ...
Posted by Michael Wonder on 20 Oct 2025
Fast track granted by FDA for NNZ-2591 in Phelan-McDermid syndrome
20 October 2025 - Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 for ...
Posted by Michael Wonder on 19 Oct 2025
Artiva Biotherapeutics announces refractory rheumatoid arthritis as lead indication
16 October 2025 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to AlloNK (also ...