Blog
RSS FeedPosted by Michael Wonder on 04 Mar 2026
Affinia Therapeutics granted FDA fast track designation for AFTX-201 as a treatment for people living with BAG3-associated dilated cardiomyopathy
4 March 2026 - Affinia Therapeutics today announced that the US FDA has granted fast track designation for AFTX-201, a potential ...
Posted by Michael Wonder on 03 Mar 2026
Johnson & Johnson therapy nipocalimab granted US FDA fast track designation in systemic lupus erythematosus
3 March 2026 - Johnson & Johnson today announced that nipocalimaba was granted US FDA fast track designation as a potential ...
Posted by Michael Wonder on 25 Feb 2026
Siren Biotechnology receives FDA fast track designation for SRN-101 for the treatment of recurrent high grade glioma
24 February 2026 - Siren Biotechnology today announced that the US FDA has granted fast track designation to SRN-101, the ...
Posted by Michael Wonder on 25 Feb 2026
Aktis Oncology receives US FDA fast track designation for AKY-1189, a nectin-4 miniprotein radioconjugate
24 February 2026 - Aktis Oncology today announced that the US FDA has granted fast track designation to AKY-1189 for the ...
Posted by Michael Wonder on 24 Feb 2026
Artios receives US FDA fast track designation for DNA polymerase theta inhibitor ART6043 for treatment of gBRCA-mutated HER2 negative breast cancer
23 February 2026 - Artios Pharma today announced that the US FDA granted fast track designation to its potentially first ...
Posted by Michael Wonder on 23 Feb 2026
Tessera Therapeutics receives US FDA fast track and orphan drug designations for its lead in vivo gene editing program TSRA-196 for the treatment of adults with AATD
23 February 2026 - Tessera Therapeutics today announced that the US FDA has granted fast track and orphan drug designations to ...
Posted by Michael Wonder on 19 Feb 2026
Pilatus Biosciences receives FDA fast track designation for metabolic checkpoint inhibitor PLT012 in hepatocellular carcinoma
19 February 2026 - Pilatus Biosciences today announced that the US FDA has granted fast track designation for PLT012, the ...
Posted by Michael Wonder on 12 Feb 2026
99mTc-maraciclatide granted FDA fast track designation for the visualisation of inflammation in interstitial lung disease
12 February 2026 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as ...
Posted by Michael Wonder on 10 Feb 2026
FGFR4 inhibitor irpagratinib granted FDA fast track designation for HCC patients
10 February 2026 - Abbisko Therapeutics announced that the US FDA has granted fast track designation to irpagratinib (ABSK-011), a ...
Posted by Michael Wonder on 05 Feb 2026
Oncolytics Biotech receives FDA fast track designation for pelareorep in second-line KRAS mutant MSS metastatic colorectal cancer
4 February 2026 - Pelareorep now has fast track designation for two gastro-intestinal cancers, solidifying its potential as an immunotherapeutic ...
Posted by Michael Wonder on 05 Feb 2026
Leads Biolabs' GPRC5D/CD3 bispecific T-cell engager LBL-034 earns FDA fast track designation—accelerating launch of potential best in class therapy for relapsed/refractory multiple myeloma
27 January 2026 - Nanjing Leads Biolabs today announced that its key investigational asset LBL-034, a GPRC5D/CD3 bi-specific antibody with a ...
Posted by Michael Wonder on 04 Feb 2026
Cumberland Pharmaceuticals receives FDA fast track designation for its ifetroban Duchenne muscular dystrophy program
4 February 2026 - Cumberland Pharmaceuticals announced today that the US FDA has granted fast track designation for its novel oral ...
Posted by Michael Wonder on 02 Feb 2026
MoonLake announces FDA fast track designation for sonelokimab palmoplantar pustulosis
2 February 2026 - MoonLake Immunotherapeutics today announces that the FDA has granted fast track designation for sonelokimab for the treatment ...
Posted by Michael Wonder on 29 Jan 2026
QTX-2101 awarded FDA fast track designation for the treatment of acute promyelocytic leukaemia
29 January 2026 - Quetzal Therapeutics announced that the US FDA has granted fast track designation to QTX-2101, the company’s ...
Posted by Michael Wonder on 27 Jan 2026
Innovent announces IBI3003 (GPRC5D/BCMA/CD3 trispecific antibody) receives fast track designation from the US FDA for relapsed or refractory multiple myeloma
27 January 2026 - Innovent Biologics announced that its anti-GPRC5D/BCMA/CD3 tri-specific antibody IBI3003 has received fast track designation from the US ...