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RSS FeedPosted by Michael Wonder on 24 Jul 2024
Tiziana Life Sciences granted FDA fast track designation
24 July 2024 - Tiziana Life Sciences today announced the US FDA has granted fast track designation for its intranasal formulation ...
Posted by Michael Wonder on 24 Jul 2024
BioAtla granted FDA fast track designation for ozuriftamab vedotin (CAB-ROR2-ADC) for treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck
23 July 2024 - Ozuriftamab vedotin, the Company’s conditionally and reversibly active antibody drug conjugate directed against ROR2, has shown promising ...
Posted by Michael Wonder on 19 Jul 2024
Diamyd Medical receives second US FDA fast track designation for Diamyd - for the prevention of type 1 diabetes
18 July 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) to ...
Posted by Michael Wonder on 18 Jul 2024
Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine
15 July 2024 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the company’s unique ...
Posted by Michael Wonder on 17 Jul 2024
Longeveron announces US FDA grants fast track designation for Lomecel-B for the treatment of mild Alzheimer’s disease
17 July 2024 - Second designation received for Lomecel-B for the treatment of mild Alzheimer’s disease after regenerative medicine advanced therapeutics ...
Posted by Michael Wonder on 16 Jul 2024
Arrivo announces FDA fast track designation for RABI-767 for patients with acute pancreatitis predicted to progress to severe disease
15 July 2024 - RABI-767 is a novel lipase inhibitor currently in a Phase 2a clinical trial. ...
Posted by Michael Wonder on 16 Jul 2024
Sumitomo Pharma announces that DSP-5336 has received FDA fast track designation for the treatment of relapsed or refractory acute myeloid leukaemia
15 July 2024 - -- Sumitomo Pharma today announced that the US FDA granted fast track designation to DSP-5336 for ...
Posted by Michael Wonder on 13 Jul 2024
FDA grants fast track designation to 9MW2821 for the treatment of patients with locally advanced or metastatic nectin-4 positive TNBC
12 July 2024 - Mabwell announces that its self-developed novel nectin-4-targeting ADC (9MW2821) has been granted fast track designation by the ...
Posted by Michael Wonder on 12 Jul 2024
AskBio receives FDA fast track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson’s disease
11 July 2024 - Bayer AG and Asklepios BioPharmaceutical today announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 10 Jul 2024
Obsidian Therapeutics announces FDA fast track designation for OBX-115 for the treatment of advanced melanoma
9 July 2024 - Obsidian Therapeutics today announced that the US FDA has granted fast track designation to OBX-115, a ...
Posted 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 ...