Blog
RSS FeedPosted by Michael Wonder on 21 Jan 2025
Solid Biosciences receives FDA fast track designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
21 January 2025 - Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and ...
Posted by Michael Wonder on 21 Jan 2025
Life Molecular Imaging secures FDA fast track designation for [18F] florbetaben in diagnosing cardiac AL and ATTR amyloidosis
21 January 2025 - [18F] florbetaben has been granted a fast track designation for cardiac amyloidosis, which will expedite the development ...
Posted by Michael Wonder on 14 Jan 2025
Lokon Pharma receives FDA fast track designation for LOAd703 for the treatment of pancreatic cancer
10 January 2025 - Lokon Pharma today announced that the US FDA has granted fast track designation for the company´s product ...
Posted by Michael Wonder on 13 Jan 2025
FDA grants fast track designation to Spinogenix's SPG601 for treatment of Fragile X syndrome, a common inherited form of autism
13 January 2025 - -- Spinogenix today announced that the US FDA has granted fast track designation to SPG601 for the ...
Posted by Michael Wonder on 12 Jan 2025
BridgeBio Oncology Therapeutics granted US FDA fast track designation for BBO-8520 for KRASG12C mutated metastatic non-small cell lung cancer
9 January 2025 - The US FDA has granted fast track designation to BBO-8520 for the treatment of adult patients with ...
Posted by Michael Wonder on 12 Jan 2025
Mersana Therapeutics announces additional FDA fast track designation granted to emiltatug ledadotin (XMT-1660)
10 January 2025 - Mersana Therapeutics today announced the US FDA recently granted an additional fast track designation to XMT-1660. ...
Posted by Michael Wonder on 09 Jan 2025
PureTech receives FDA fast track designation for LYT-200 in acute myeloid leukaemia
9 January 2024 - Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of ...
Posted by Michael Wonder on 09 Jan 2025
Marengo’s first in class invikafusp alfa (STAR0602) receives US FDA fast track designation for treatment of unresectable, locally advanced, or metastatic colorectal cancers with high tumour mutational burden
8 January 2025 - Initial safety and efficacy data from Phase 1 STARt-001 trial showed promising single agent clinical activity ...
Posted by Michael Wonder on 09 Jan 2025
Johnson & Johnson’s posdinemab and tau active immunotherapy receive US FDA fast track designations for the treatment of Alzheimer’s disease
8 January 2025 - Building on decades of the Company’s Alzheimer’s research, two differentiated investigational therapies aim to slow pathological tau ...
Posted by Michael Wonder on 08 Jan 2025
Vergent Bioscience receives FDA fast track designation for abenacianine for injection (VGT-309) to help surgeons visualise tumours in the lung during surgery
7 January 2025 - Abenacianine is an investigational tumour targeted fluorescent imaging agent that has demonstrated a promising safety profile and ...
Posted by Michael Wonder on 07 Jan 2025
Restem receives FDA fast track designation for Restem-L for idiopathic inflammatory myopathy
7 January 2025 - Second regulatory designation for Restem-L, a lead ULSC program, following the recent orphan drug designation. ...
Posted by Michael Wonder on 06 Jan 2025
Star Therapeutics receives FDA fast track designation for VGA039 in von Willebrand disease
6 January 2025 - VGA039 is potentially the first subcutaneous therapy that addresses all types of von Willebrand disease and has a ...
Posted by Michael Wonder on 22 Dec 2024
LimmaTech awarded FDA fast track designation for vaccine candidate against Staphylococcus aureus
19 December 2024 - LimmaTech Biologics announced today that the US FDA has granted fast track designation to LimmaTech’s multivalent ...
Posted by Michael Wonder on 22 Dec 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory Waldenstrom’s macroglobulinaemia
19 December 2024 - Fast track designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenstrom’s macroglobulinaemia. ...
Posted by Michael Wonder on 22 Dec 2024
BioGenCell receives FDA fast track designation with expanded access for BGC101
19 December 2024 - BioGenCell announced that the US FDA has granted fast track designation to its lead candidate, BGC101, ...