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RSS FeedPosted by Michael Wonder on 06 Oct 2021
US FDA grants fast track designation for JR-171 for the treatment of mucopolysaccaridosis type I
5 October 2021 - JCR Pharmaceuticals announced today that the US FDA has granted fast track designation for the investigational drug ...
Posted by Michael Wonder on 30 Sep 2021
DiaMedica Therapeutics announces fast track designation granted to DM199 for the treatment of acute ischaemic stroke
30 September 2021 - DiaMedica Therapeutics today announced that the U.S. FDA has granted fast track designation to the Company’s lead ...
Posted by Michael Wonder on 29 Sep 2021
NuCana receives fast track designation from the U.S. Food and Drug Administration for Acelarin (NUC-1031) for the treatment of biliary tract cancer
29 September 2021 - NuCana announced that the U.S. FDA has granted fast track designation to Acelarin (NUC-1031), currently being evaluated ...
Posted by Michael Wonder on 25 Sep 2021
CARISMA Therapeutics announces U.S. FDA grants fast track designation to CT-0508 for the treatment of patients with solid tumours
22 September 2021 - CARISMA Therapeutics announced today that that the U.S. FDA has granted fast track designation to CT-0508, ...
Posted by Michael Wonder on 24 Sep 2021
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted fast track designation by the US FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma
22 September 2021 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a fast track ...
Posted 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 ...