Tags : Indication

Chipscreen Bioscience’s Epidaza (chidamide) Receives NMPA Approval for Breast Cancer

Shots: The approval follows P-III ACE study assessing chidamide + exemestane demonstrated PFS benefit and the includes Chidamide + aromatase inhibitor in postmenopausal patients with HR+, HER2- advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression Chidamide (CS055/HBI-8000/tucidinostat) is an orally available low-nanomolar inhibitor of cancer-associated histone deacetylase (HDAC) enzymes targeting subtype […]Read More

Medtronic Resolute Drug-Eluting Stent (DES) Platform Receives FDA’s Approval for

Shots: The expanded indication approval is based on PERSPECTIVE Study assessing 183 patients with older-generation Resolute Integrity DES The study resulted in low rates of repeat revascularization 1.1%, cardiac death 2.2%, minimal stent thrombosis 0.06% and safe results Resolute Drug-Eluting Stent (DES) platform includes Resolute Onyx and Resolute Integrity DES targeted for the treatment of […]Read More

Amgen’s Blincyto (blinatumomab) Receives EU Expanded Indication Approval for Ph-

Shots: The expanded approval is based on P-II BLAST study results assessing Blincyto (15ug/m2/d @4wks.) in patients with 3L + MRD-positive ALL in complete hematologic remission, evaluating its efficacy, safety, and tolerability The study resulted in complete MRD response or no detectable MRD, relapse-free survival, eliminating detectable residual disease with safe and effective results in […]Read More