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Regulatory
FDA opens Operation TrialBlazer for applications, hoping to reshore early trials
The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.
September 15, 2026
·
1 min read
·
Heather McKenzie
Press Releases
Evecxia Therapeutics Announces Positive Clinical Results From a Phase 1b Target Engagement Trial
September 15, 2026
·
3 min read
Press Releases
FDA Accepts Curi Bio’s Letter of Intent into ISTAND Program to Qualify 3D Neuromuscular Junction Assay as a Non-Animal Replacement for Botulinum Toxin Potency Testing
September 15, 2026
·
4 min read
Press Releases
Claritev Appoints Ben Letham to its Board of Directors
September 15, 2026
·
3 min read
Press Releases
RegCell Secures $66 Million of Additional Funding to Bring Nobel-Winning Immune Tolerance Science to the Clinic
September 15, 2026
·
6 min read
Press Releases
A2 Biotherapeutics Presents Early Safety and Efficacy Data from the DENALI-1 Study of A2B395, Highlighting First Reported Case of Complete Response to CAR T-Cell Therapy in Anal Cancer and Partial Response at 6 Months in Refractory Head & Neck Cancer
September 15, 2026
·
7 min read
Press Releases
BostonGene Expands Scientific Collaboration with Leading Cancer Institute to Advance Breast Cancer Research
September 15, 2026
·
3 min read
Press Releases
CEL-SCI Invited to Deliver Keynote Address on Multikine at 6th World Congress on Otology, Rhinology and Laryngology
September 15, 2026
·
5 min read
Press Releases
Asahi Kasei Introduces VANTIJ® SU-VFC Benchtop to Improve Efficiency and Consistency in Gene Therapy Manufacturing
September 15, 2026
·
3 min read
Press Releases
Amprion Launches SAAmplify®-αSYN Plus: The First & Only Commercially Available CSF Test to Detect Alpha-Synuclein Profile for Multiple System Atrophy
September 15, 2026
·
4 min read
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