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RSS FeedPosted by Michael Wonder on 19 Jul 2022
Wugen receives US FDA fast track and rare paediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL
19 July 2022 - Wugen, today announced that the U.S. FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 19 Jul 2022
Peptilogics receives FDA fast track designation for PLG0206, an investigational peptide therapeutic in development for the treatment of peri-prosthetic joint infection
19 July 2022 - PLG0206 has the potential to be the first approved therapy specifically indicated for the treatment of peri-prosthetic ...
Posted by Michael Wonder on 19 Jul 2022
Daewoong's idiopathic pulmonary fibrosis drug gets FDA's fast track status
19 July 2022 - Daewoong Pharmaceutical said that the US FDA had granted fast track designation to its idiopathic pulmonary ...
Posted by Michael Wonder on 14 Jul 2022
FDA grants Alpheus Medical orphan drug and fast track designations for novel sonodynamic therapy for brain cancer
13 July 2022 - The company is currently enrolling patients in a multicentre Phase 1 clinical trial for the treatment ...
Posted by Michael Wonder on 11 Jul 2022
Anthos Therapeutics announces that abelacimab has received FDA fast track designation for the treatment of thrombosis associated with cancer
11 July 2022 - Abelacimab is a dual-acting fully human monoclonal antibody targeting both factor XI and Factor XIa with high ...
Posted by Michael Wonder on 06 Jul 2022
InflaRx receives FDA fast track designation for treatment of ulcerative pyoderma gangrenosum
6 July 2022 - Fast track follows recently reported orphan drug designation by both US FDA and EMA ...
Posted by Michael Wonder on 30 Jun 2022
Aura Biosciences receives FDA fast track designation for belzupacap sarotalocan (AU-011) for the treatment of non-muscle invasive bladder cancer
30 June 2022 - Aura Biosciences today announced that the U.S. FDA has granted fast track designation for belzupacap sarotalocan (AU-011), ...
Posted by Michael Wonder on 28 Jun 2022
Apnimed granted FDA fast track designation for AD109, a novel first in class oral pharmacologic combination for the treatment of obstructive sleep apnoea
28 June 2022 - Additional Phase 2b data evaluating AD109 as potential treatment for obstructive sleep apnoea anticipated in Q3 ...
Posted by Michael Wonder on 22 Jun 2022
Ikena Oncology receives FDA fast track designation for novel TEAD inhibitor IK-930 to treat unresectable NF2 deficient mesothelioma
22 June 2022 - Ikena Oncology today announced that the U.S. FDA has granted fast track designation for IK-930, the Company’s ...
Posted by Michael Wonder on 21 Jun 2022
Paratek Pharmaceuticals’ Nuzyra receives FDA fast track designation for the treatment of pulmonary non-tuberculous mycobacterial disease caused by mycobacterium avium complex and mycobacterium abscessus
21 June 2022 - Phase 2b study in MAB pulmonary infections on-going and enrolling as planned. ...
Posted by Michael Wonder on 16 Jun 2022
Kintara Therapeutics granted fast track designation from the FDA for VAL-083 for newly diagnosed glioblastoma
15 June 2022 - swire/ -- Kintara Therapeutics today announced that the United States FDA has granted fast track designation to ...
Posted by Michael Wonder on 09 Jun 2022
AlgoTx’s ATX01 granted fast track designation by FDA for chemotherapy-induced neuropathic pain
9 June 2022 - AlgoTx announced today that it has received fast track designation from the U.S. FDA for the ...
Posted by Michael Wonder on 08 Jun 2022
FDA grants fast track designation for BioCryst’s ALK-2 inhibitor, BCX9250
8 June 2022 - BioCryst Pharmaceuticals today announced the U.S. FDA has granted fast track designation for BCX9250 for the ...
Posted by Michael Wonder on 02 Jun 2022
PDS Biotechnology granted FDA fast track designation for lead candidate PDS0101
2 June 2022 - PDS Biotech has been granted fast track designation for PDS0101 in combination with Keytruda (pembrolizumab) for ...
Posted by Michael Wonder on 02 Jun 2022
Accutar Biotechnology announces fast track designation granted by FDA to AC0176 for the treatment of metastatic castration resistant prostate cancer
1 June 2022 - Accutar Biotechnology today announced that the U.S. FDA has granted fast track designation to AC0176 for ...