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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Jun 2022
Fast track designation granted to MTX110 development for the treatment of recurrent glioblastoma
1 June 2022 - Midatech Pharma is pleased to announce that upon submitting an application to the U.S. FDA, its development ...
Posted by Michael Wonder on 31 May 2022
Priothera receives fast track designation for mocravimod in combination with allogeneic haematopoietic stem cell transplant for post remission therapy of acute myeloid leukaemia patients
31 May 2022 - Priothera today announces that the U.S. FDA has granted fast track designation for mocravimod in combination with ...
Posted by Michael Wonder on 26 May 2022
Pfizer granted FDA fast track designation for ervogastat/clesacostat combination for the treatment of non-alcoholic steatohepatitis
26 May 2022 - Pfizer today announced the U.S. FDA has granted fast track designation to Pfizer’s investigational combination therapy ...
Posted by Michael Wonder on 25 May 2022
Elevation Oncology announces FDA fast track designation granted to seribantumab for the tumour agnostic treatment of solid tumours harbouring NRG1 gene fusions
25 May 2022 - Elevation Oncology today announced that the U.S. FDA has granted fast track designation to seribantumab for the ...
Posted by Michael Wonder on 24 May 2022
Blue Lake Biotechnology announces FDA fast track designation for BLB-201 intranasal RSV vaccine
24 May 2022 - Blue Lake Biotechnology today announced that the U.S. FDA has granted fast track designation for BLB-201, an ...
Posted by Michael Wonder on 04 May 2022
Aptose receives fast track designation for HM43239 in relapsed/refractory AML patients and FLT3 mutation
4 May 2022 - Aptose Biosciences today announced that the U.S. FDA has granted fast track designation to HM43239, an oral, ...