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RSS FeedPosted by Michael Wonder on 21 Sep 2021
Inventiva announces FDA decision that fast track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis
21 September 2021 - Inventiva today announced that the U.S. FDA has decided that the fast track designation previously granted to ...
Posted by Michael Wonder on 20 Sep 2021
Aveo Oncology announces ficlatuzumab granted fast track designation by the U.S. FDA for the treatment of relapsed or recurrent head and neck squamous cell carcinoma
20 September 2021 - Aveo Oncology today announced that the U.S. FDA has granted fast frack designation to ficlatuzumab for the ...
Posted by Michael Wonder on 17 Sep 2021
BridgeBio Pharma receives FDA fast track designation for investigational therapy for the treatment of limb-girdle muscular dystrophy type 2i (LGMD2i)
15 September 2021 - If successful, BridgeBio's drug could be the first approved therapy for patients with LGMD2i. ...
Posted by Michael Wonder on 16 Sep 2021
Sage Therapeutics receives fast track designation for SAGE-718 for the treatment of Huntington’s disease
15 September 2021 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-718 for development ...
Posted by Michael Wonder on 15 Sep 2021
Pulmocide’s lead drug candidate opelconazole (PC945) granted orphan drug, fast track and qualified infectious disease product designations by US FDA
15 September 2021 - Pulmocide today announced that the US FDA has granted orphan drug, fast track and qualified infectious disease ...
Posted by Michael Wonder on 14 Sep 2021
ISA Pharmaceuticals receives fast track designation for lead product ISA101b
14 September 2021 - Fast track designation for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer to improve ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 09 Sep 2021
Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations
9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...
Posted by Michael Wonder on 08 Sep 2021
HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU
8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...
Posted by Michael Wonder on 02 Sep 2021
Novartis gets FDA fast track designation for LNA043 in knee osteoarthritis
2 September 2021 - Novartis AG on Thursday said the U.S. FDA granted fast track designation to LNA043 for the ...
Posted by Michael Wonder on 24 Aug 2021
Humanetics Corporation’s BIO 300 receives fast track designation from FDA
24 August 2021 - Humanetics announced today that BIO 300, a drug under development to increase survival in persons exposed to ...
Posted by Michael Wonder on 19 Aug 2021
Senhwa's silmitasertib receives US FDA fast track designation for the treatment of recurrent sonic hedgehog driven medulloblastoma
19 August 2021 - Senhwa Biosciences today announced that the US FDA has granted fast track designation for silmitasertib, a highly ...
Posted by Michael Wonder on 18 Aug 2021
Sutro Biopharma announces STRO-002 FDA fast track designation for patients with advanced ovarian cancer
18 August 2021 - Sutro Biopharma today announced that the U.S. FDA has granted fast track designation for STRO-002, a folate ...
Posted by Michael Wonder on 16 Aug 2021
Edgewise receives U.S. FDA fast track designation for EDG-5506 for the treatment of individuals with Becker muscular dystrophy
16 August 2021 - EDG-5506, a drug candidate designed to arrest muscle fibre breakdown in Becker and Duchenne muscular dystrophy, continues to ...
Posted by Michael Wonder on 16 Aug 2021
Carrick Therapeutics receives FDA fast track designations for two samuraciclib combinations for the treatment of HR+, HER2- advanced breast cancer and locally advanced or metastatic triple negative breast cancer
16 August 2021 - Carrick Therapeutics today announced that the U.S. FDA has granted Fast Track designations to samuraciclib in combination ...