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RSS FeedPosted by Michael Wonder on 09 Jul 2024
Adicet Bio receives FDA fast track designation for ADI-270 in metastatic/advanced clear cell renal cell carcinoma
8 July 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-270 for the ...
Posted by Michael Wonder on 05 Jul 2024
Hinova Pharmaceuticals receives FDA fast track designation for HP518 for treatment of androgen receptor triple-negative breast cancer
5 July 2024 - Hinova Pharmaceuticals today announced that the US FDA has granted fast track designation for HP518, an investigational ...
Posted by Michael Wonder on 04 Jul 2024
Full-Life Technologies granted FDA fast track designation for 225Ac-FL-020 for the treatment of metastatic castration resistant prostate cancer
2 July 2024 - Full-Life Technologies today announced that the US FDA has granted fast track designation for 225Ac-FL-020, the company's ...
Posted by Michael Wonder on 03 Jul 2024
Inozyme Pharma announces FDA fast track designation for INZ-701 in ABCC6 deficiency
2 July 2024 - Inozyme Pharma today announced that the US FDA has granted fast track designation to INZ-701 for ...
Posted by Michael Wonder on 03 Jul 2024
"99mTc-maraciclatide" granted FDA fast track designation for the diagnosis of superficial peritoneal endometriosis
2 July 2024 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as a ...
Posted by Michael Wonder on 02 Jul 2024
Syncromune granted FDA fast track designation for SYNC-T SV-102 for the treatment of metastatic castrate-resistant prostate cancer
1 July 2024 - Syncromune today announced that the US FDA has granted fast track designation for SYNC-T SV-102 therapy, its ...
Posted by Michael Wonder on 29 Jun 2024
Tubulis receives FDA fast track designation for antibody drug conjugate candidate TUB-040 in platinum-resistant ovarian cancer
27 June 2024 - Designation for TUB-040 in platinum-resistant ovarian cancer is based on preclinical data in a range of models, ...
Posted by Michael Wonder on 29 Jun 2024
Abdera Therapeutics announces FDA fast track designation for ABD-147, a next generation precision radiopharmaceutical therapy, for the treatment of patients with extensive-stage small cell lung cancer
27 June 2024 - Abdera Therapeutics today announced that the US FDA has granted fast track designation to ABD-147 for the ...
Posted by Michael Wonder on 27 Jun 2024
Vir Biotechnology receives FDA fast track designation for tobevibart and elebsiran for the treatment of chronic hepatitis delta infection
26 June 2024 - Fast Track designation follows positive preliminary Phase 2 trial data presented at the European Association for ...
Posted by Michael Wonder on 27 Jun 2024
Carisma Therapeutics granted FDA fast track designation for CT-0525 for the treatment of HER2 overexpressing solid tumours
25 June 2024 - Initial Phase 1 data expected by year end 2024. ...
Posted by Michael Wonder on 25 Jun 2024
Oncoinvent receives FDA fast track designation for Radspherin as treatment for peritoneal carcinomatosis from ovarian cancer
24 June 2024 - Phase 2b trial of Radspherin to treat ovarian cancer patients expected to initiate imminently. ...
Posted by Michael Wonder on 25 Jun 2024
BioNTech and DualityBio receive FDA fast track designation for antibody-drug conjugate candidate BNT324/DB-1311 in prostate cancer
24 June 2024 - Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with ...
Posted by Michael Wonder on 13 Jun 2024
Innovent receives fast track designation from the US FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
12 June 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its TOPO1i anti-CLDN18.2 ADC ...
Posted by Michael Wonder on 10 Jun 2024
FDA grants fast track designation to GCBP and Novel Pharma's GC1130A
10 June 2024 - GC Biopharma and Novel Pharma have announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 10 Jun 2024
SpliSense receives FDA fast track designation for SPL84 for the treatment of cystic fibrosis
29 May 2024 - SpliSense today announced that the US FDA has granted fast track designation to SPL84 for cystic ...