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RSS FeedPosted by Michael Wonder on 13 Aug 2024
Insignis Therapeutics receives FDA fast track designation for IN-001 for anaphylaxis treatment
13 August 2024 - Convenient, needle-free, and simple to use liquid epinephrine sublingual spray. ...
Posted by Michael Wonder on 01 Aug 2024
Corvus Pharmaceuticals granted FDA fast track designation for soquelitinib for treatment of patients with relapsed or refractory peripheral T-cell lymphoma
1 August 2024 - Soquelitinib registrational Phase 3 clinical trial in PTCL advancing toward initial enrollment in Q3, 2024. ...
Posted by Michael Wonder on 01 Aug 2024
Immuneering granted FDA fast track designation for IMM-1-104 in first-line pancreatic cancer
31 July 2024 - IMM-1-104 fast track designation now granted for the treatment of both first and second-line pancreatic ductal adenocarcinoma. ...
Posted by Michael Wonder on 26 Jul 2024
Tonix Pharmaceuticals granted fast track designation by FDA for Tonmya for fibromyalgia
25 July 2024 - NDA submission on track for second half 2024. ...
Posted by Michael Wonder on 26 Jul 2024
AC Immune’s ACI-35.030 (now “JNJ-2056”) granted FDA fast track designation for Alzheimer’s aisease
25 July 2024 - Treatment of first randomised person with pre-clinical Alzheimer's disease expected this quarter. ...
Posted 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 ...