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RSS FeedPosted 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 ...
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 ...