Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
NICE Recommends Lynparza for BRCA1/2-Mutant Breast Cancer
The institute originally began reviewing Lynparza in this setting in 2018 but ended its review due to lack of evidence.
Dizal Pharmaceutical Seeking FDA Approval for Sunvozertinib in EGFR Exon 20 Insertion-Mutated NSCLC
Chinese regulators approved the drug for the same subset of advanced, previously treated EGFR-mutated NSCLC patients in 2023.
With new treatments in neurology, and more in development in cardiology and autoimmune diseases, precision medicine is moving beyond cancer and rare disease.
Innovent's Dovbleron Gains Approval in China for ROS1-Positive NSCLC
The firm also out-licensed its DLL3 antibody-drug conjugate candidate, IBI3009, to Roche this week.
BeiGene Nabs FDA Approval for Tevimbra With Chemo in First-Line PD-L1-Positive Gastric Cancer
Patients on the Tevimbra combo had a 20 percent reduction in risk of death compared to those on chemotherapy alone.