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RSS FeedPosted by Michael Wonder on 26 Sep 2018
FDA grants QIDP and fast track designations to Cidara Therapeutics’ rezafungin prophylaxis development program
25 September 2018 - Rezafungin designated for the prevention of invasive fungal infections in adults undergoing bone marrow transplantation. ...
Posted by Michael Wonder on 24 Sep 2018
MicuRx announces receipt of FDA’s QIDP and fast track designations for contezolid and contezolid acefosamil
21 September 2018 - MicuRx Pharmaceuticals today announced the receipt of the qualified infectious disease product classification and grant of fast ...
Posted by Michael Wonder on 21 Sep 2018
Adverum Biotechnologies receives fast track designation for ADVM-022 gene therapy for the treatment of wAMD
19 September 2018 - ADVM-022 is a unique single-administration gene therapy delivered intra-vitreally for the treatment of wAMD. ...
Posted by Michael Wonder on 14 Sep 2018
Miransertib (ARQ 092) granted fast track designation for the treatment of PIK3CA-related overgrowth spectrum
13 September 2018 - ArQule today announced that the U.S. FDA has granted fast track designation to miransertib (ARQ 092) for ...
Posted by Michael Wonder on 14 Sep 2018
Ironwood Pharmaceuticals announces FDA fast track designation for praliciguat for the treatment of heart failure with preserved ejection fraction
13 September 2018 - Praliciguat Phase II trial in HFpEF continues to enrol patients with top-line data expected in the second ...
Posted by Michael Wonder on 12 Sep 2018
FibroGen receives fast track designation from the U.S. FDA for pamrevlumab for the treatment of idiopathic pulmonary fibrosis
12 September 2018 - FibroGen today announced that the U.S.FDA has granted fast track designation for the company’s anti-CTGF antibody, pamrevlumab, ...
Posted by Michael Wonder on 11 Sep 2018
Bertilimumab granted fast track designation for the treatment of bullous pemphigoid
11 September 2018 - Company to provide corporate update during conference call with live audio webcast on Thursday 13 September at ...
Posted by Michael Wonder on 07 Sep 2018
Fibrocell announces FDA fast track designation of FCX-013 for treatment of moderate to severe localised scleroderma
5 September 2018 - Fibrocell Science today announced that the U.S. FDA has granted fast track designation to FCX-013, the Company’s ...
Posted by Michael Wonder on 03 Sep 2018
FDA grants Insys Therapeutics ‘fast track’ designation for epinephrine nasal spray as investigational treatment for anaphylaxis
30 August 2018 - Insys Therapeutics announced today that the U.S. FDA has granted fast track designation to the company’s epinephrine ...
Posted by Michael Wonder on 28 Aug 2018
Cantex Pharmaceuticals receives FDA fast track designation for CX-01 for the treatment of patients over age 60 with newly diagnosed acute myeloid leukaemia
27 August 2018 - Cantex Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for Cantex's lead product ...
Posted by Michael Wonder on 24 Aug 2018
Mallinckrodt and NPXe announce FDA fast track designation for Phase 3 trial of inhaled Xenon gas therapy
23 August 2018 - Drug to be studied for improved functional outcomes and survival rates for patients resuscitated after a cardiac ...
Posted by Michael Wonder on 21 Aug 2018
MeiraGTx announces AAV-CNGB3 granted fast track designation by U.S. FDA for treatment of achromatopsia
20 August 2018 - MeiraGTx today announced that the U.S. FDA has granted fast track designation for its AAV-CNGB3 gene therapy ...
Posted by Michael Wonder on 20 Aug 2018
U.S. FDA grants fast track designation to Aravive Biologics’ AVB-S6-500
20 August 2018 - Aravive Biologics announced today that the U.S. FDA has granted fast track designation to AVB-S6-500 as a ...
Posted by Michael Wonder on 11 Aug 2018
Castle Creek Pharmaceuticals receives FDA fast track designation for diacerein 1% ointment for treatment of epidermolysis bullosa simplex
9 August 2018 - Biopharmaceutical company currently evaluating diacerein 1% ointment in ongoing DELIVERS study. ...
Posted by Michael Wonder on 09 Aug 2018
Sesen Bio announces Vicinium granted fast track designation by FDA for treatment of non-muscle invasive bladder cancer
9 August 2018 - Sesen Bio today announced that the U.S. FDA has granted fast track designation to Vicinium for the ...