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RSS FeedPosted 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 ...
Posted by Michael Wonder on 27 Jan 2026
Drug Farm announces FDA fast track designation for first in class ALPK1 inhibitor DF-003 for the treatment of ROSAH syndrome
27 January 2026 - Drug Farm today announced that the US FDA has granted fast track designation to DF-003, its investigational, ...
Posted by Michael Wonder on 22 Jan 2026
BioNTech receives FDA fast track designation for mRNA cancer immunotherapy candidate BNT113 in HPV16+ head and neck cancer
21 January 2026 - BioNTech today announced that the US FDA has granted fast track designation to BNT113, an investigational mRNA ...
Posted by Michael Wonder on 21 Jan 2026
Scynexis receives FDA qualified infectious disease product and fast track designations for SCY-247
21 January 2026 - Scynexis today announced that the US FDA has granted the Company qualified infectious disease product and fast ...
Posted by Michael Wonder on 21 Jan 2026
LBL-024 (opamtistomig PD-L1/4-1BB bispecific antibody) granted fast track designation by the US FDA
14 January 2026 - The Company is pleased to announce that LBL-024 (opamtistomig), a PD-L1/4-1BB bispecific antibody, was granted fast ...
Posted by Michael Wonder on 20 Jan 2026
Ouro Medicines receives US FDA fast track designation for gamgertamig in immune thrombocytopenia and auto-immune haemolytic anaemia
20 January 2026 - Ouro Medicines today announced that gamgertamig (OM336), the company's BCMAxCD3 T cell engager antibody investigational candidate, has ...
Posted by Michael Wonder on 09 Jan 2026
VectorY Therapeutics receives FDA fast track designation for VTx-002, a first in class vectorised antibody targeting underlying disease biology in ALS
8 January 2026 - VectorY Therapeutics announced today that the US FDA has granted fast track designation for VTx-002, a first-in-class ...
Posted by Michael Wonder on 09 Jan 2026
858 Therapeutics announces FDA fast track designation for PARG inhibitor ETX-19477 for the treatment of patients with BRCA mutated, platinum resistant ovarian cancer
8 January 2026 - 858 Therapeutics today announced that the US FDA has granted fast track designation to ETX-19477, the company’s ...
Posted by Michael Wonder on 09 Jan 2026
Alessa Therapeutics announces FDA fast track designation for Enolen, a first of its kind treatment for localised prostate cancer
8 January 2026 - Alessa Therapeutics today announced that the US FDA has granted fast track designation for Enolen, the ...
Posted by Michael Wonder on 09 Jan 2026
Complement Therapeutics announces FDA fast track designation for CTx001 for the treatment of geographic atrophy secondary to AMD
8 January 2025 - Complement Therapeutics today announced that the US FDA has granted fast track designation for CTx001, the company's ...