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RSS FeedPosted by Michael Wonder on 18 Nov 2019
Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome
18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) ...
Posted by Michael Wonder on 18 Nov 2019
Seelos Therapeutics receives FDA fast track designation for intranasal racemic ketamine (SLS-002)
18 November 2019 - Seelos Therapeutics today announced the U.S. FDA has granted fast track designation to its new, investigational intranasal ...
Posted by Michael Wonder on 13 Nov 2019
Viracta receives fast track designation for nanatinostat combination for the treatment of EBV-associated lymphomas
12 November 2019 - Viracta Therapeutic, announced today that the U.S. FDA has granted fast track designation for nanatinostat in ...
Posted by Michael Wonder on 09 Nov 2019
Triumvira Immunologics announces fast track designation for its first TAC T-Cell therapeutic product candidate: TAC01-CD19
7 November 2019 - Designation confirms significant unmet need remains in DLBCL. ...
Posted by Michael Wonder on 09 Nov 2019
EIP Pharma announces U.S. FDA grants fast-track designation to neflamapimod as a treatment for dementia with Lewy Bodies
7 November 2019 - EIP Pharma today announced that the Division of Neurology Products of the U.S. FDA has granted ...
Posted by Michael Wonder on 06 Nov 2019
Bionomics announces fast track designation granted by U.S. FDA to BNC210 development program for the treatment of PTSD
4 November 2019 - Bionomics announced today that the U.S. FDA has granted fast track designation to the BNC210 development program ...
Posted by Michael Wonder on 29 Oct 2019
Terns Pharmaceuticals receives fast track designation from the FDA for TERN-101, an FXR agonist for the treatment of NASH
29 October 2019 - Terns Pharmaceuticals today announced that TERN-101, an investigational farnesoid X receptor (FXR) agonist, has been granted fast ...
Posted by Michael Wonder on 28 Oct 2019
U.S. FDA grants fast track designation to Astellas for the development of ASP1128 for patients at risk for acute kidney injury
28 October 2019 - Astellas Pharma today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
Posted by Michael Wonder on 22 Oct 2019
Moderna receives FDA fast track designation for propionic acidemia program (mRNA-3927)
22 October 2019 - mRNA-3927 is Moderna’s second rare disease program to receive fast track designation. ...
Posted by Michael Wonder on 22 Oct 2019
BerGenBio receives FDA approval of fast track designation for bemcentinib
22 October 2019 - BerGenBio today announces that the U.S FDA has approved fast track designation for bemcentinib for the treatment ...
Posted by Michael Wonder on 15 Oct 2019
Xenikos receives FDA fast track designation for T-Guard(R) for treating steroid-refractory acute graft-versus-host disease
14 October 2019 - Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial. ...
Posted by Michael Wonder on 10 Oct 2019
FDA grants FX-322 fast track designation
10 October 2019 - The company also announced today that the U.S. FDA has granted fast track designation for FX-322. ...
Posted by Michael Wonder on 10 Oct 2019
Swissmedic reviewing licence extension for the SGLT2 inhibitor Invokana (canagliflozin) in fast-track procedure
9 October 2019 - The CREDENCE renal outcomes study, which was stopped early in July 2018 owing to positive efficacy findings, ...
Posted by Michael Wonder on 07 Oct 2019
Mereo BioPharma receives FDA fast track designation for navicixizumab for the treatment of heavily pre-treated ovarian cancer
7 October 2019 - Mereo BioPharma today announces that the U.S. FDA has granted fast track designation to navicixizumab for the ...
Posted by Michael Wonder on 01 Oct 2019
Geron announces fast track designation granted to imetelstat for relapsed/refractory myelofibrosis
30 September 2019 - Geron Corporation today announced that the United States FDA has granted fast track designation to imetelstat for ...