The FDA granted 510(k) clearance to the Dayspring Lite treatment for lymphedema and venous disease.
The FDA granted Breakthrough Device designation to the Novilase Interstitial Laser System and its proposed indication for use: the focal destruction of malignant breast tumors in adult women seeking a breast conserving procedure.
The FDA granted Fast Track designation to Acelarin (NUC-1031), currently being evaluated in a phase III study, NuTide:121, for the first-line treatment of patients with advanced biliary tract cancer.
The FDA accepted for priority review the supplemental Biologics License Application for PD-1 inhibitor Libtayo (cemiplimab-rwlc), a monoclonal antibody, to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
The FDA issued a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.
MD Anderson Cancer Center and BostonGene Corporation formed a strategic alliance to advance the development and clinical integration of multiplatform biomarker signatures.
Jakafi (ruxolitinib) has received FDA approval for treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Cabometyx (cabozantinib) has received FDA approval for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible.
Brukinsa (zanubrutinib) has received FDA accelerated approval for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
The FDA granted accelerated approval to Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
