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RSS FeedPosted by Michael Wonder on 21 Apr 2018
U.S. FDA grants fast track designation for Polyphor's innovative immuno-oncology candidate balixafortide in combination with eribulin as third-line therapy for metastatic breast cancer
19 April 2018 - Polyphor announced today that the U.S. FDA has granted fast track designation for its novel immuno-oncology candidate ...
Posted by Michael Wonder on 18 Apr 2018
Calithera Biosciences announces FDA fast track designation granted to CB-839 in combination with cabozantinib for treatment of patients with advanced renal cell carcinoma
18 April 2018 - Randomised CANTATA trial open for enrolment. ...
Posted by Michael Wonder on 13 Apr 2018
Rhizen Pharmaceuticals receives FDA fast track designation for tenalisib (RP6530), a highly selective dual PI3K delta/gamma inhibitor for the treatment of patients with relapsed and/or refractory cutaneous T-cell lymphoma
13 April 2018 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for tenalisib, the Company’s ...
Posted by Michael Wonder on 11 Apr 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with penta-refractory multiple myeloma
10 April 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to the company’s lead, ...
Posted by Michael Wonder on 04 Apr 2018
Proteostasis Therapeutics receives FDA fast track designation for triple combination program in patients with cystic fibrosis
4 April 2018 - Proteostasis Therapeutics today announced that the U.S. FDA has granted fast track designation for the company's triple ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA grants fast track designation to Taris for TAR-200 (GemRIS) in muscle invasive bladder cancer
3 April 2018 - Designation for patients unfit for curative intent therapy. ...
Posted by Michael Wonder on 21 Mar 2018
Fennec Pharmaceuticals receives fast track designation by FDA for Pedmark
21 March 2018 - Fennec Pharmaceuticals today announced that the U.S. FDA has granted Pedmark (a unique formulation of sodium thiosulfate) ...
Posted by Michael Wonder on 19 Mar 2018
FDA grants fast track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease
19 March 2018 - The designation is based on the investigational new drug application for SSc-ILD and the anticipated efficacy and ...
Posted by Michael Wonder on 15 Mar 2018
Destiny Pharma announces FDA fast track designation for lead clinical candidate, exeporfinium chloride
15 March 2018 - Destiny Pharma today announces that its lead clinical candidate exeporfinium chloride (XF-73) has been granted Fast ...
Posted by Michael Wonder on 15 Mar 2018
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Fragile X syndrome
15 March 2018 - Second fast track designation for OV101 within three months. ...
Posted by Michael Wonder on 14 Mar 2018
NovaBiotics’ Lynovex receives fast track designation for cystic fibrosis exacerbations
12 March 2018 - NovaBiotics announces receipt of fast track designation for its cystic fibrosis therapy, Lynovex, from the United States ...
Posted by Michael Wonder on 01 Mar 2018
FibroGen granted fast track designation by U.S. FDA for pamrevlumab treatment of patients with locally advanced unresectable pancreatic cancer
1 March 2018 - FibroGen today announced that the U.S. FDA has granted fast track designation for the company’s anti-CTGF antibody, ...
Posted by Michael Wonder on 23 Feb 2018
Evofem Biosciences receives fast track designation for Amphora for prevention of Chlamydia
21 February 2018 - Evofem Biosciences today announced that the U.S. FDA has granted fast track designation for Amphora (L-lactic acid, ...
Posted by Michael Wonder on 17 Feb 2018
Allecra Therapeutics announces fast track designation for lead antibiotic in resistant infections
14 February 2018 - Supports Allecra’s lead program in Phase 2 clinical trials to treat serious gram-negative infections. ...
Posted by Michael Wonder on 08 Feb 2018
Ensysce Biosciences receives fast track designation for PF614, BIO-MD abuse deterrent extended release oxycodone prodrug
29 January 2018 - Ensysce Biosciences is pleased to announce that the FDA has granted Fast Track designation for the development ...