Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
FDA Clears Kinnate Biopharma's IND for FGFR Inhibitor in Bile Duct, Urothelial Cancers
The firm will begin a trial evaluating KIN-3248 as a treatment for patients with FGFR2/3-altered tumors during the first half of 2022.
AstraZeneca, Daiichi Sankyo File for FDA Enhertu Approval in Second-Line HER2-Postive Breast Cancer
The agency has accepted the firms' supplemental biologics application for the antibody-drug conjugate and is expected to make a decision by Q2 2022.
JP Morgan Healthcare Conference Day 3: Iovance, Elevation Oncology, Autolus, and More
Highlights of the third day included details on Iovance's regulatory progress on its TIL therapy, Elevation's seribantumab, and Precigen's UltraCAR-T therapies.
Black Diamond Therapeutics IND for BDTX-1535 Cleared by FDA
The company will initiate a Phase I trial of the MasterKey inhibitor in EGFR-mutated glioblastoma multiforme and non-small cell lung cancer.
NeoGenomics Blood-Based Minimal Residual Disease Test Receives CE Mark
NeoGenomics subsidiary Inivata has also submitted the RaDaR test to the MolDx program in the US for reimbursement.Â