FDA clearance
Lyell Immunopharma's IND for T-Cell Receptor Therapy Gets FDA Clearance
The company will begin a Phase I trial of LYL132 in certain patients with NY-ESO-1-expressing advanced sarcomas.
23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test
The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance.
FDA Clears Jubilant Therapeutics' IND Allowing for LSD1/HDAC6 Inhibitor Clinical Trial
The company will evaluate JBI-802 in solid tumors, including small cell lung cancer and treatment-induced neuroendocrine prostate cancer.
Regor Therapeutics to Begin US CDK2/4/6 Inhibitor Study for HR-Positive, HER2-Negative Breast Cancer
Following FDA clearance, the firm will assess its investigational agent, RGT-419B, as treatment for advanced HR-positive, HER2-negative breast cancer patients.
Lyell Immunopharma Receives IND Clearance for Phase I Trial of CAR T-Cell Therapy for ROR1-Expressing TNBC, NSCLC
The company hopes to begin screening patients for ROR1 expression in the first quarter of 2022 and report initial data in 2023.
Mar 30, 2021