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RSS FeedPosted by Michael Wonder on 15 Feb 2024
Diamyd Medical receives US FDA fast track designation for Diamyd
15 February 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) that ...
Posted by Michael Wonder on 13 Feb 2024
CAN-3110 receives FDA fast track designation for treatment of recurrent high-grade glioma
13 February 2024 - Candel Therapeutics today announced that the US FDA granted fast track designation for CAN-3110 -- a first ...
Posted by Michael Wonder on 13 Feb 2024
Edgewise receives US FDA fast track designation for EDG-5506 for the treatment of Duchenne muscular dystrophy
13 February 2024 - Edgewise Therapeutics today announced that the US FDA has granted fast track designation for EDG-5506 for the ...
Posted by Michael Wonder on 12 Feb 2024
BioXcel Therapeutics receives FDA fast track designation for BXCL701 for treatment of small cell neuroendocrine prostate cancer
12 February 2024 - BXCL701 is an investigational, oral innate immune activator designed to inflame the tumour microenvironment and augment CPI ...
Posted by Michael Wonder on 12 Feb 2024
GSK receives US FDA fast track designation for bepirovirsen in chronic hepatitis B
12 February 2024 - Designation underscores the unmet need for medicines that can achieve functional cure in patients with chronic ...
Posted by Michael Wonder on 08 Feb 2024
Eplontersen granted US FDA fast track designation for patients with transthyretin-mediated amyloid cardiomyopathy
8 February 2024 - Ionis Pharmaceuticals announced today that the US FDA has granted fast track designation to Ionis and ...
Posted by Michael Wonder on 06 Feb 2024
Arvinas and Pfizer’s vepdegestrant (ARV-471) receives FDA fast track designation for the treatment of patients with ER positive/HER2 negative metastatic breast cancer
6 February 2024 - Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC) protein degrader designed to target and degrade the ...
Posted by Michael Wonder on 05 Feb 2024
Ultimovacs receives FDA fast track designation for UV1 cancer vaccine for the treatment of patients with unresectable mesothelioma
5 February 2024 - The designation was granted by the US FDA based on results from the randomised Phase II clinical ...
Posted by Michael Wonder on 01 Feb 2024
Biosyngen announces FDA fast track designation for BST02 in treatment of liver cancer
1 February 2024 - Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted fast track designation ...
Posted by Michael Wonder on 01 Feb 2024
BioNTech and DualityBio receive FDA fast track designation for next generation antibody drug conjugate candidate BNT325/DB-1305
31 January 2024 - Designation is based on preliminary safety and efficacy data from an on-going Phase 1/2 trial in patients ...
Posted by Michael Wonder on 30 Jan 2024
Ascidian Therapeutics announces fast tracks ACDN-01 in Stargardt disease and other ABCA4 retinopathies
29 January 2024 - Ascidian Therapeutics today announced that the US FDA has granted fast track ...
Posted by Michael Wonder on 19 Jan 2024
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in the treatment of patients with refractory progressive multiple sclerosis
19 January 2024 - The announcement follows the recent IND clearance for KYV-101 to be used in Kyverna's KYSA-7 Phase 2 ...
Posted by Michael Wonder on 18 Jan 2024
Verastem Oncology granted fast track designation for combination of avutometinib and sotorasib for the treatment of KRAS G12C mutant non-small-cell lung cancer
18 January 2024 - On-going RAMP 203 trial assessing a more complete vertical blockade with RAF/MEK and KRAS G12C inhibition along ...
Posted by Michael Wonder on 16 Jan 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory CLL and SLL
16 January 2024 - Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports ...
Posted by Michael Wonder on 16 Jan 2024
NRx Pharmaceuticals announces FDA qualified infectious disease product and fast track designation of NRX-101 in complicated urinary tract infection and pyelonephritis
16 January 2024 - QIDP designation grants priority review and an additional 5 years of additional product exclusivity. ...