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RSS FeedPosted by Michael Wonder on 05 Sep 2024
Innovent receives fast track designation from the US FDA for IBI363 (PD-1/IL-2α bispecific antibody fusion protein) as monotherapy for advanced melanoma
4 September 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its PD-1/IL-2α bispecific antibody ...
Posted by Michael Wonder on 03 Sep 2024
Caribou Biosciences announces the FDA has granted fast track designations to CB-010 in refractory SLE and to CB-012 in relapsed or refractory AML
3 September 2024 - Additional FDA designation for CB-010 following earlier RMAT and fast track designations in B-NHL. ...
Posted by Michael Wonder on 29 Aug 2024
Life Molecular Imaging receives FDA fast track designation for [18F]PI-2620 in Tau PET imaging across three neurodegenerative conditions
28 August 2024 - Life Molecular Imaging is pleased to announce that the US FDA granted fast track designation to [18F]PI-2620 ...
Posted by Michael Wonder on 27 Aug 2024
FDA grants fast track designation for bexmarilimab
26 August 2024 - Faron Pharmaceuticals today announces that their lead candidate bexmarilimab has been granted fast track designation for the ...
Posted by Michael Wonder on 26 Aug 2024
BeiGene’s BGB-16673 receives US FDA fast track designation for CLL/SLL
26 August 2024 - Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with ...
Posted by Michael Wonder on 25 Aug 2024
FDA grants fast track designation to Aveta Biomics’ drug APG-157 for neo-adjuvant treatment of head and neck cancer
22 August 2024 - Aveta Biomics is pleased to announce that the US FDA has granted fast track designation to APG-157, ...
Posted 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. ...