October 9th, 2026FDA Grants Fast Track Designation to PSV359 for Advanced FAP-Positive Solitary Fibrous TumorsThe FDA granted fast track designation to PSV359 for locally advanced unresectable or metastatic FAP-positive solitary fibrous tumors.Read more
October 1st, 2026UTRxMYCN M1-14 Nets FDA Dual Designations in Soft Tissue SarcomaUTRxMYCN M1-14 received orphan drug status for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma.Read more
September 30th, 2026FDA Approves Denosumab Biosimilar for Skeletal-Related Events, GCTB, and Hypercalcemia of MalignancyDenosumab-adet (Degevma) is FDA-approved as an Xgeva biosimilar for SRE prevention in myeloma and bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy.Read more