Patients on the firm's SSTR-targeted radiopharmaceutical had improved progression-free survival compared to patients on an mTor inhibitor in a Phase III trial.
The agency approved the drug based on data from the DESTINY-Breast06 trial, which included patients who had tumors with very low HER2 expression.
The FDA, which has stopped short of requiring DPYD testing for patients before receiving fluoropyrimidines, emphasized the ...
The positive results from the second part of the EMBARK trial contrast with findings from one-year post treatment, which did ...
The trial will include patients with non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.
With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.
The firm said it has received positive feedback from the FDA on the design of a Phase III trial of ELI-002 in KRAS-mutant pancreatic cancer.
Their study showed that DCIS patients with pathogenic variants in BRCA1/2 and PALB2 had a higher risk of developing invasive breast cancer than those without.
The Shanghai-based firm will test the gene therapy candidate in patients between 4 and 9 years old with Duchenne muscular dystrophy.
BH-30643 is an OMNI-EGFR inhibitor that targets classical, atypical, and compound EGFR mutations and acquired resistance mutations in HER2.
The companies will focus on advancing AXV-101, with which they hope to treat retinal dystrophy by targeting mutations in the BBS1 gene.