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RSS FeedPosted by Michael Wonder on 18 Feb 2022
Immune-Onc Therapeutics receives FDA fast track designation for IO-202, the first anti-LILRB4 myeloid checkpoint inhibitor, for the treatment of relapsed or refractory acute myeloid leukaemia
17 February 2022 - Immune-Onc Therapeutics today announced that the U.S. FDA has granted fast track designation for IO-202, a first ...
Posted by Michael Wonder on 18 Feb 2022
Dizal Pharmaceutical receives U.S. FDA fast track designation for DZD4205 (golidocitinib) for the treatment of refractory or relapsed peripheral T-cell lymphoma
18 February 2022 - Fast track designation proves Dizal's world leading capability of developing potential first-in-class and much needed therapy to ...
Posted by Michael Wonder on 17 Feb 2022
FDA grants fast track designation to SBT101, the first investigational AAV based gene therapy for patients with adrenomyeloneuropathy
16 February 2022 - Initiation of Phase 1/2 clinical trial expected in the second half of 2022. ...
Posted by Michael Wonder on 16 Feb 2022
Poxel announces FDA fast track status for PXL065 in X linked adrenoleukodystrophy
16 February 2022 - The initiation of the Phase IIa proof of concept clinical study for PXL065 in adrenoleukodystrophy is now ...
Posted by Michael Wonder on 14 Feb 2022
Axcella Therapeutics announces FDA fast track designation for AXA1125 in NASH
14 February 2022 - EMMPACT Phase 2b clinical trial enrolling well, with interim data expected in mid 2022. ...
Posted by Michael Wonder on 10 Feb 2022
Bayer receives U.S. FDA fast track designation for asundexian stroke program
10 February 2022 - Bayer today announced that the U.S. FDA has granted fast track designation for its investigational drug ...
Posted by Michael Wonder on 07 Feb 2022
NGM Bio’s NGM621 receives fast track designation from the FDA for the treatment of patients with geographic atrophy secondary to age-related macular degeneration
7 February 2022 - NGM Biopharmaceuticals today announced that the U.S. FDA has granted fast track designation to NGM621, a monoclonal ...
Posted by Michael Wonder on 01 Feb 2022
Veru announces FDA grant of fast track designation for sabizabulin for the treatment of hospitalised COVID-19 patients at high risk for acute respiratory distress syndrome
31 January 2022 - Second Veru drug under development to receive FDA fast track designation this month. ...
Posted by Michael Wonder on 25 Jan 2022
SNIPR BIOME announces US FDA grants fast track designation for SNIPR001 for prevention of bloodstream infections in haematologic cancer patients
25 January 2022 - SNIPR Biome has been granted fast track designation by the US FDA for SNIPR001. ...
Posted by Michael Wonder on 25 Jan 2022
Senhwa’s pidnarulex receives US FDA fast track designation for the treatment of solid tumours with BRCA1/2, PALB2 and other HR gene mutations
24 January 2022 - Senhwa Biosciences announced today that the US FDA has granted fast track designation for Pidnarulex, a first ...
Posted by Michael Wonder on 20 Jan 2022
Celcuity receives FDA fast track designation for gedatolisib in HR positive, HER2 negative metastatic breast cancer
18 January 2022 - On track to finalise Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter. ...
Posted by Michael Wonder on 18 Jan 2022
Antares Pharma receives FDA fast track designation for ATRS-1902 for adrenal crisis rescue
18 January 2022 - Antares Pharma today announced that the U.S. FDA has granted fast track designation for ATRS-1902 for adrenal ...
Posted by Michael Wonder on 18 Jan 2022
Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastro-oesophageal junction cancers
18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...
Posted by Michael Wonder on 11 Jan 2022
4D Molecular Therapeutics announces FDA fast track designation granted to 4D-125 for the treatment of X-linked retinitis pigmentosa
10 January 2022 - 4D Molecular Therapeutics announced that the U.S. FDA has granted fast track designation for 4D-125 for treatment ...
Posted by Michael Wonder on 11 Jan 2022
Veru announces FDA grant of fast track designation for enobosarm for the treatment of androgen receptor positive, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer
10 January 2022 - Phase 3 ARTEST registration study of enobosarm in patients with androgen receptor positive, oestrogen receptor positive, human ...