Blog
RSS FeedPosted 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, ...
Posted by Michael Wonder on 18 Dec 2024
FDA grants fast track designation to Lipocine for LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis
17 December 2024 - Lipocine today announced that the US FDA has granted fast track designation to LPCN 1148 as a ...
Posted by Michael Wonder on 13 Dec 2024
Phanes Therapeutics’ PT217 granted fast track designation by the FDA for NEPC
4 December 2024 - This is the second fast track designation granted to PT217 by the agency ...
Posted by Michael Wonder on 12 Dec 2024
Immuneering granted FDA fast track designation for IMM-1-104 in advanced melanoma
12 December 2024 - MM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative ...
Posted by Michael Wonder on 12 Dec 2024
Two combination vaccine candidates for prevention of influenza and COVID-19 granted fast track designation in the US
11 December 2024 - Two Phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by ...
Posted by Michael Wonder on 12 Dec 2024
EpicentRx's oncolytic virus-delivered TGFβ Inhibitor, AdAPT-001, receives FDA fast track designation for recurrent or refractory soft tissue sarcoma treatment
5 December 2024 - EpicentRx announced today that the US FDA granted fast track designation for the oncolytic adenovirus-delivered transforming growth ...
Posted by Michael Wonder on 07 Dec 2024
Lantern Pharma's investigational drug candidate, LP-184, receives second fast track designation from FDA for treatment of triple negative breast cancer
3 December 2024 - LP-184 has demonstrated significant pre-clinical efficacy in triple negative breast cancer models, including those resistant to PARP ...
Posted by Michael Wonder on 07 Dec 2024
FDA grants fast track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer
3 December 2024 - Corbus Pharmaceuticals announced today that the US FDA has granted fast track designation to CRB-701 for the ...
Posted by Michael Wonder on 06 Dec 2024
Rigel announces R289 granted fast track designation by the FDA for lower risk myelodysplastic syndrome
2 December 2024 - Rigel Pharmaceuticals today announced that the US FDA has granted fast track designation to R289 for the ...
Posted by Michael Wonder on 06 Dec 2024
Sana Biotechnology announces fast track designation for SC291 in relapsed/refractory systemic lupus erythematosus
2 December 2025 - Enrolling patients in the GLEAM trial for SC291 in B-cell mediated auto-immune diseases, including systemic lupus erythematosus; ...