Blog
RSS FeedPosted by Michael Wonder on 02 Apr 2026
A2 Biotherapeutics receives US FDA fast track designation for A2B543, a logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster
1 April 2026 - A2 Biotherapeutics today announced that the US FDA has granted fast track designation for A2B543, an autologous ...
Posted by Michael Wonder on 31 Mar 2026
Zymeworks receives US FDA fast track designation for ZW191, a folate receptor alfa targeting antibody drug conjugate
30 March 2026 - Zymeworks today announced that the US FDA has granted fast track designation to ZW191, an antibody ...
Posted by Michael Wonder on 25 Mar 2026
Triana Biomedicines’ TRI-611 granted US FDA fast track designation for treatment of ALK positive non-small cell lung cancer
25 March 2026 - Triana Biomedicines today announced that the US FDA granted fast track designation for TRI-611, an investigational molecular ...
Posted by Michael Wonder on 19 Mar 2026
Remix Therapeutics granted FDA fast track designation for REM-422 for the treatment of recurrent, metastatic or unresectable adenoid cystic carcinoma
19 March 2026 - Remix Therapeutics today announced that the US FDA has granted fast track designation to first-in-class small molecule ...
Posted by Michael Wonder on 18 Mar 2026
FluoGuide receives FDA fast track designation for FG001 in high grade glioma
18 March 2026 - FluoGuide announces that the US FDA has granted fast track designation to FG001 as an intra-operative imaging ...
Posted by Michael Wonder on 17 Mar 2026
Polaryx Therapeutics receives FDA fast track designation for PLX‑200 for late‑infantile neuronal ceroid lipofuscinosis
17 March 2026 - Regulatory milestone supports advancement of the SOTERIA Phase 2 basket trial evaluating PLX‑200 across multiple lysosomal storage ...
Posted by Michael Wonder on 17 Mar 2026
Argo Biopharma receives FDA fast track designation for BW-20805, an investigational siRNA therapy for the treatment of HAE
16 March 2026 - Global Phase 2 open-label study in adult hereditary angioedema patients on-going, company on track for primary completion ...
Posted by Michael Wonder on 12 Mar 2026
ARTHEx Biotech granted FDA fast track designation for ATX-01 for the treatment of myotonic dystrophy type 1
11 March 2026 - ARTHEx Biotech today announced that the US FDA has granted fast track designation to ATX-01 for the ...
Posted by Michael Wonder on 12 Mar 2026
Quoin Pharmaceuticals announces FDA grants fast track designation for QRX003 for the treatment of Netherton syndrome
11 March 2026 - Quoin Pharmaceuticals today announced that the US FDA has granted fast track designation to QRX003 lotion (4%) ...
Posted by Michael Wonder on 10 Mar 2026
Redx’s RXC008 granted US FDA fast track designation for fibrostenotic Crohn’s disease
10 March 2026 - Redx Pharma announces that the US FDA has granted fast track designation to RXC008, a GI ...
Posted by Michael Wonder on 09 Mar 2026
Precision BioSciences receives FDA fast track sesignation for PBGENE-DMD
9 March 2026 - Precision BioSciences today announced that the US FDA has granted fast track designation to PBGENE-DMD for the ...
Posted 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 ...