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RSS FeedPosted 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 ...
Posted by Michael Wonder on 11 Jan 2022
COUR Pharmaceuticals receives FDA fast track designation for CNP-104 for the treatment of primary biliary cholangitis
10 January 2021 - COUR Pharmaceuticals today announced the U.S. FDA granted fast track designation to the Company's investigational therapy CNP-104 ...
Posted by Michael Wonder on 07 Jan 2022
Dynacure receives fast track designation for DYN101, an investigational antisense oligonucleotide for the treatment of myotubular and centronuclear myopathies
6 January 2022 - Dynacure today announced that the U.S. FDA has granted fast track designation for its lead product ...
Posted by Michael Wonder on 04 Jan 2022
Genprex receives U.S. FDA fast track designation for Reqorsa immunogene therapy in combination with Keytruda for the treatment of non-small-cell lung cancer
3 January 2022 - Second FDA fast track designation further validates the potential of Reqorsa. ...
Posted by Michael Wonder on 03 Jan 2022
FDA grants ILiAD Biotechnologies fast track designation for next generation pertussis vaccine BPZE1
3 January 2021 - ILiAD Biotechnologies, today announced that the U.S. FDA has granted fast track designation to BPZE1, a next ...
Posted by Michael Wonder on 28 Dec 2021
Vivoryon Therapeutics receives FDA fast track designation for varoglutamstat in early Alzheimer’s disease
22 December 2021 - 21 – Vivoryon Therapeutics today announced that the U.S. FDA has granted fast track designation for varoglutamstat ...
Posted by Michael Wonder on 27 Dec 2021
Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-001 in development for the treatment of AML
27 December 2021 - Celularity today announced the U.S. FDA has granted fast track designation for its non-genetically modified cryopreserved human ...
Posted by Michael Wonder on 26 Dec 2021
Lion TCR receives FDA fast track designation for its HBV specific TCR T cell therapy for hepatocellular carcinoma
23 December 2021 - Lion TCR today announced that it has received fast track designation from U.S. FDA for LioCyx-M004, autologous ...