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RSS FeedPosted by Michael Wonder on 09 Jul 2020
Assembly Biosciences announces FDA fast track designation granted to ABI-H2158 for the treatment of chronic hepatitis B virus infection
9 July 2020 - Assembly Biosciences today announced that the U.S. FDA has granted fast track designation to ABI-H2158 (2158) for ...
Posted by Michael Wonder on 03 Jul 2020
MetVital announces FDA fast track designation of anhydrous enol-oxaloacetate for the treatment of patients with newly diagnosed glioblastoma multiforme
1 July 2020 - MetVital today announces that the U.S. FDA has notified MetVital that its lead drug candidate, "Anhydrous ...
Posted by Michael Wonder on 01 Jul 2020
Sun BioPharma receives FDA fast track designation for SBP-101
30 June 2020 - Sun BioPharma today announced receipt of fast track designation from the U.S. FDA for its lead product, ...
Posted by Michael Wonder on 30 Jun 2020
Nordic Nanovector's Betalutin receives fast track designation from US FDA for marginal zone lymphoma
29 June 2020 - Nordic Nanovector today announces that the US FDA has granted fast track designation for investigating Betalutin (177Lu ...
Posted by Michael Wonder on 24 Jun 2020
NeuroRx and Relief Therapeutics announce fast track designation granted by the FDA to RLF-100 (aviptadil) for the treatment of respiratory distress in COVID-19
24 June 2020 - At the FDA’s request, NeuroRx is submitting an expanded access policy enabling physicians to request RLF-100 for ...
Posted by Michael Wonder on 24 Jun 2020
Renibus Therapeutics receives FDA fast track designation for RBT-9 treatment in COVID-19
23 June 2020 - Renibus Therapeutics announced today that it has been granted fast track designation by the FDA for RBT-9 ...
Posted by Michael Wonder on 23 Jun 2020
Polynoma receives FDA fast track designation for its melanoma cancer vaccine seviprotimut-L
23 June 2020 - Polynoma announces that the U.S. FDA has granted its application for fast track designation of seviprotimut-L, ...
Posted by Michael Wonder on 18 Jun 2020
Linnaeus Therapeutics granted U.S. FDA fast track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on anti-PD-1/L1 therapy
18 June 2020 - Company Conducting Ongoing Phase 1/2 Study of LNS8801. ...
Posted by Michael Wonder on 18 Jun 2020
Chi-Med announces fruquintinib granted U.S. FDA fast track designation for metastatic colorectal cancer
18 June 2020 - Hutchison China MediTech today announces that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 17 Jun 2020
Ipsen receives FDA fast track designation for liposomal irinotecan (Onivyde) as a first-line combination treatment for metastatic pancreatic cancer
17 June 2020 - Final analysis of the Phase 1/2 clinical study to be presented as a late-breaking virtual presentation at ...
Posted by Michael Wonder on 13 Jun 2020
ZZ Biotech announces FDA fast track designation for stroke program
12 June 2020 - ZZ Biotech today announced that the US FDA has designated the investigation of the company’s experimental drug ...
Posted by Michael Wonder on 04 Jun 2020
TVAX Biomedical receives fast track designation from the FDA for brain cancer
4 June 2020 - TVAX Biomedical announced today receipt of fast track designation from the U.S. FDA for the use of ...
Posted by Michael Wonder on 28 May 2020
Cardiff Oncology announces fast track designation granted by the FDA to onvansertib for second-line treatment of KRAS mutated colorectal cancer
28 May 2020 - Fast Track designation for onvansertib in KRAS mutated metastatic colorectal cancer underscores the urgent need for new ...
Posted by Michael Wonder on 27 May 2020
Cellectar receives FDA fast track designation for CLR 131 in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinaemia
26 May 2020 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in lymphoplasmacytic ...
Posted by Michael Wonder on 26 May 2020
Protara Therapeutics receives fast track designation from U.S. FDA for intravenous choline chloride for the treatment of intestinal failure associated liver disease
26 May 2020 - Protara Therapeutics today announced that the U.S. FDA has granted fast track designation to intravenous choline chloride ...