Blog
RSS FeedPosted by Michael Wonder on 01 Feb 2024
BioNTech and DualityBio receive FDA fast track designation for next generation antibody drug conjugate candidate BNT325/DB-1305
31 January 2024 - Designation is based on preliminary safety and efficacy data from an on-going Phase 1/2 trial in patients ...
Posted by Michael Wonder on 30 Jan 2024
Ascidian Therapeutics announces fast tracks ACDN-01 in Stargardt disease and other ABCA4 retinopathies
29 January 2024 - Ascidian Therapeutics today announced that the US FDA has granted fast track ...
Posted by Michael Wonder on 19 Jan 2024
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in the treatment of patients with refractory progressive multiple sclerosis
19 January 2024 - The announcement follows the recent IND clearance for KYV-101 to be used in Kyverna's KYSA-7 Phase 2 ...
Posted by Michael Wonder on 18 Jan 2024
Verastem Oncology granted fast track designation for combination of avutometinib and sotorasib for the treatment of KRAS G12C mutant non-small-cell lung cancer
18 January 2024 - On-going RAMP 203 trial assessing a more complete vertical blockade with RAF/MEK and KRAS G12C inhibition along ...
Posted by Michael Wonder on 16 Jan 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory CLL and SLL
16 January 2024 - Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports ...
Posted by Michael Wonder on 16 Jan 2024
NRx Pharmaceuticals announces FDA qualified infectious disease product and fast track designation of NRX-101 in complicated urinary tract infection and pyelonephritis
16 January 2024 - QIDP designation grants priority review and an additional 5 years of additional product exclusivity. ...
Posted by Michael Wonder on 14 Jan 2024
RemeGen's RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients
12 January 2024 - RemeGen announced recently that its independently developed mesothelin targeting antibody drug conjugate RC88 has been granted fast ...
Posted by Michael Wonder on 09 Jan 2024
Seres Therapeutics announces US FDA fast track designation for SER-155
9 January 2024 - SER-155 Phase 1b placebo controlled Cohort 2 data readout anticipated in third quarter of 2024. ...
Posted by Michael Wonder on 09 Jan 2024
Sellas Life Sciences receives FDA fast track designation for SLS009 for treatment of relapsed/refractory acute myeloid leukaemia
9 January 2024 - Sellas Life Sciences Group today announced that the US FDA has granted fast track designation to SLS009 ...
Posted by Michael Wonder on 08 Jan 2024
Cabaletta Bio receives additional FDA fast track designations for CABA-201 in dermatomyositis and systemic sclerosis
8 January 2024 - Second and third FDA fast track designations for CABA-201, following the systemic lupus erythematosus and lupus ...
Posted by Michael Wonder on 08 Jan 2024
FDA grants Soligenix fast track designation for dusquetide in the treatment of oral lesions of Behçet's disease
8 January 2024 - Soligenix announced today that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's ...
Posted by Michael Wonder on 05 Jan 2024
ProfoundBio announces rinatabart sesutecan FDA fast track designation for patients with advanced ovarian cancer
5 January 2023 - ProfoundBio today announced that the US FDA has granted fast track designation for rinatabart sesutecan (Rina-S; ...
Posted by Michael Wonder on 27 Dec 2023
Imaging Biometrics granted FDA fast track
19 December 2023 - Imaging Biometrics is pleased to announce that the US FDA has granted fast track designation for oral ...
Posted by Michael Wonder on 27 Dec 2023
FDA grants fast track designation to Henlius’ EGFR targeting ADC HLX42 for NSCLC patients with disease progression on EGFR targeted therapies
27 December 2023 - Shanghai Henlius Biotech announced that the US FDA granted fast track designation for HLX42, an investigational EGFR ...
Posted by Michael Wonder on 18 Dec 2023
Lexeo Therapeutics granted FDA fast track designation and orphan drug designation for LX2020, an AAV based gene therapy candidate for PKP2 arrhythmogenic cardiomyopathy
18 December 2023 - Lexeo Therapeutics today announced the US FDA has granted fast track designation and orphan drug designation to ...