Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Lantern Pharma Gains FDA Clearance to Test LP-184 in Non-Small Cell Lung Cancer Subset
The firm will test the drug with immune checkpoint inhibitors in NSCLC patients with low PD-L1 expression and KEAP1 and/or STK11 mutations.
FDA Grants Regenxbio Priority Review for MPS II Gene Therapy Regulatory Application
The FDA will issue a decision on the BLA for RGX-121 by November, which if positive, could make it the first gene therapy for Hunter syndrome.
Hoth Therapeutics Eyeing Human Trials for HT-KIT Antisense Therapy in Early 2026
After seeing promising results in preclinical studies, the firm hopes to begin Phase I trials shortly after getting IND clearance.
FDA Clears Ensoma's IND to Launch Immune Disorder Gene Therapy Trial
EN-374 is a gene therapy designed to treat X-linked chronic granulomatous disease by modifying hematopoietic stem cells in vivo.
UTR Therapeutics Submits IND Application for mRNA Destabilizer
If the agency approves its application, the firm will begin a Phase I clinical trial in c-MYC-driven cancers in 2026.