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RSS FeedPosted by Michael Wonder on 14 Jan 2021
Innovation Pharmaceuticals’ brilacidin for the treatment of COVID-19 receives FDA fast track designation
14 January 2021 - Innovation Pharmaceuticals is pleased to announce that the U.S. FDA has designated as a fast track development ...
Posted by Michael Wonder on 13 Jan 2021
Leading BioSciences announces FDA fast track designation granted to LB1148 for the treatment of post-operative gastro-intestinal dysfunction associated with paediatric cardiovascular surgery
13 January 2021 - LBS expects to initiate a pivotal trial in 2021. ...
Posted by Michael Wonder on 11 Jan 2021
Exicure granted two fast track designations for cavrotolimod (AST-008) from the U.S. Food and Drug Administration
11 January 2021 - Exicure today announced that the U.S. FDA has granted fast track designations for its clinical product ...
Posted by Michael Wonder on 07 Jan 2021
Gemini Therapeutics announces FDA fast track designation granted for GEM103 for the treatment of dry age-related macular degeneration in patients with complement factor H loss of function gene variants
7 January 2020 - Gemini Therapeutics today announced that GEM103, the Company’s investigational treatment for dry age-related macular degeneration, has been ...
Posted by Michael Wonder on 07 Jan 2021
Merus granted FDA fast track designation of zenocutuzumab for the treatment of patients with neuregulin 1 fusion cancers
7 January 2021 - NRG1 fusions are rare mutations in many types of solid tumours, including non-small cell lung cancer and ...
Posted by Michael Wonder on 07 Jan 2021
RedHill Biopharma's RHB-204 granted FDA fast track designation for non-tuberculous mycobacteria disease
6 January 2021 - FDA Fast Track designation, together with previously granted QIDP designation, provides RHB-204 with eligibility for rolling NDA ...
Posted by Michael Wonder on 04 Jan 2021
FDA grants ARX788 fast track designation for HER2 positive metastatic breast cancer
4 January 2021 - Ambrx announced that the U.S. FDA granted ARX788 fast track designation as monotherapy for the treatment of ...
Posted by Michael Wonder on 18 Dec 2020
Novaremed receives fast track designation from the FDA for NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy
18 December 2020 - Novaremed announced today that it has received fast track designation from the U.S. FDA for the development ...
Posted by Michael Wonder on 17 Dec 2020
Decibel Therapeutics announces DB-020 has been granted fast track designation by the U.S. FDA
17 December 2020 - Decibel Therapeutics today announced that their clinical product candidate, DB-020, has been granted fast track designation ...
Posted by Michael Wonder on 16 Dec 2020
Durect Corporation announces DUR-928 granted FDA fast track designation for treatment of alcoholic hepatitis
16 December 2020 - Durect Corporation today announced that the U.S. FDA has granted fast track designation to DUR-928 for ...
Posted by Michael Wonder on 15 Dec 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of acute myeloid leukaemia
15 December 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 14 Dec 2020
Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Dec 2020
Gannex received U.S. FDA fast track designation for its NASH drug candidate ASC42, an FXR agonist
13 December 2020 - Gannex announced today that it received fast track designation from the U.S. FDA for its non-alcoholic steatohepatitis ...
Posted by Michael Wonder on 12 Dec 2020
Lexicon Pharmaceuticals receives fast track designation from the FDA for LX9211 for diabetic peripheral neuropathic pain
11 December 2020 - Lexicon Pharmaceuticals announced today that it has received Fast Track designation from the U.S. FDA for ...
Posted by Michael Wonder on 07 Dec 2020
Immunicum receives FDA fast track designation for ilixadencel in gastro-intestinal stromal tumours
7 December 2020 - Immunicum announced today that it has received fast track designation from the U.S. FDA for the Company’s ...