Blog
RSS FeedPosted by Michael Wonder on 25 Aug 2024
Abata Therapeutics receives FDA fast track designation for ABA-101 for the treatment of progressive multiple sclerosis
22 August 2024 - Abata Therapeutics today announced that the US FDA has granted fast track designation for ABA-101 for the ...
Posted by Michael Wonder on 22 Aug 2024
Clarity receives FDA fast track designation for 64Cu-SAR-bisPSMA
22 August 2024 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for 64Cu-SAR-bisPSMA ...
Posted by Michael Wonder on 20 Aug 2024
ReAlta Life Sciences granted FDA orphan drug designation and fast track designation for RLS-0071 for the treatment of steroid-refractory acute graft versus host disease
19 August 2024 - Second clinical indication for RLS-0071 to receive both orphan drug designation and fast track designation, demonstrating the ...
Posted by Michael Wonder on 20 Aug 2024
Arthrosi Therapeutics receives FDA fast track designation for AR882 in tophaceous gout
19 August 2024 - Arthrosi Therapeutics today announced the US FDA has granted fast track designation to AR882 for the potential ...
Posted by Michael Wonder on 15 Aug 2024
Accutar Biotechnology receives FDA fast track designation for AC699 in ER positive, HER2 negative breast cancer
14 August 2024 - Accutar Biotechnology announced today that the US FDA has granted the investigation of AC699 a fast track ...
Posted by Michael Wonder on 15 Aug 2024
Kiromic BioPharma’s Deltacel receives FDA fast track designation
14 August 2024 - Kiromic BioPharma announces that the US FDA has granted fast track designation to Deltacel (KB-GDT-01), the Company’s ...
Posted 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 ...