Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
European Commission Approves Keytruda in Early-Stage Triple-Negative Breast Cancer
The approval in Europe follows the FDA's approval for the same indication last year based on data from the KEYNOTE-522 trial.
Precipio Receives CE-IVD Mark for Hematologic Cancer Panels
The company said it can now market its HemeScreen MPN, AML, Anemia/MDS, and CLL panels in the European Union and the UK.
Illumina Adds CDx Indication to European TruSight Oncology Test for NTRK Gene Fusion Detection
The CDx pan-cancer indication will allow the identification of patients with NTRK gene fusions who may benefit from therapy with Bayer's Vitrakvi (larotrectinib).
Seagen Going After Tukysa, Herceptin Combo Approval in HER2-Positive Colorectal Cancer
The company plans to seek accelerated approval for the regimen after seeing a 38 percent objective response rate in the MOUNTAINEER trial.
The agency acknowledges its staff can't keep up with the volume of cell and gene therapy products and is looking to PDUFA VII for additional funds.Â