Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 19 Oct 2025
Enterome receives FDA fast track designation in follicular lymphoma for lead OncoMimics immunotherapy EO2463
16 October 2025 - Enterome announces today that the US FDA has granted fast track designation for follicular lymphoma in the ...
Posted by Michael Wonder on 17 Oct 2025
Silver Creek Pharmaceuticals receives FDA fast track designation for Scp776 in acute ischaemic stroke
17 October 2025 - Silver Creek Pharmaceuticals today announced that the US FDA has granted fast track designation to scp776, its ...
Posted by Michael Wonder on 16 Oct 2025
NovelWise Pharmaceutical receives FDA fast track designation for NBM-BMX in metastatic uveal melanoma
14 October 2025 - NovelWise Pharmaceutical today announced that the US FDA has granted fast track designation for NBM-BMX, a ...
Posted by Michael Wonder on 14 Oct 2025
Akamis Bio receives FDA fast track designation for NG-350A for the treatment of mismatch repair proficient locally advanced rectal cancer
14 October 2025 - NG-350A is a systemically delivered oncolytic immunotherapy driving intra-tumoral expression of a CD40 agonist monoclonal antibody. ...
Posted by Michael Wonder on 13 Oct 2025
FDA awards fast track designation to Epion Therapeutics for its EpiSmart epithelium on cross linking system
13 October 2025 - Epion Therapeutics today announced that the US FDA granted fast track designation for EpiSmart Epithelium-On Cross-Linking System, ...
Posted by Michael Wonder on 13 Oct 2025
Blacksmith Medicines receives FDA qualified infectious disease product and fast track designation for FG-2101, a novel antibiotic targeting LpxC
13 October 2025 - Blacksmith Medicines announced today that the US FDA has granted qualified infectious disease product and the ...
Posted by Michael Wonder on 10 Oct 2025
Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma
9 October 2025 - Adcendo ApS today announced that the US FDA has granted fast track designation to ADCE-D01 for ...