Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
FDA Clears Lion TCR to Begin Phase II Trial of TCR T-Cell Therapy in HBV-Related Liver Cancer
The firm will study its autologous cell therapy alone and in combination with Eisai's Lenvima in patients with hepatitis B-driven hepatocellular carcinoma.
Ibex AI-Driven Prostate Cancer Screening Test Nets FDA Clearance
Ibex Prostate Detect is designed to help pathologists catch small and rare cancers in whole-slide images from tissue biopsies that they might've missed.
In Brief This Week: Ocugen, Acrivon, Myriad Genetics, Ariceum, Arbor Biotechnologies
News items for the week of Feb. 3, 2025.
FDA Clears Aro Biotherapeutics' siRNA Drug IND for Late-Onset Pompe Disease
The company has already kicked off an open-label Phase I trial of ABX1100 in Canada following positive results from a study of healthy volunteers.
Fondazione Telethon Seeking Approval for Wiskott-Aldrich Syndrome Gene Therapy in Europe
Thirty patients have received the gene therapy within a clinical trial and early-access program, and the foundation also hopes to seek approval in the US.