GSK PLC (LSE/NYSE: GSK) has received regulatory approval from the National Medical Products Administration of China for Nucala (mepolizumab) as an add-on maintenance therapy for adults with eosinophilic chronic obstructive pulmonary disease (COPD) inadequately controlled on inhaled triple therapy. The greenlight marks a strategic respiratory expansion for GSK in the world’s largest COPD market and […]
Kallisio has begun clinical implementation of its FDA-cleared Stentra system at Stanford Health Care, marking the first reported integration of the patient-specific intraoral device into a major U.S. hospital’s workflow for head and neck cancer radiation therapy. The system, which received 510(k) clearance in January 2024, enables individualized immobilization of oral structures during intensity-modulated radiation […]
RevBio Inc. has received clearance from the United States Food and Drug Administration to begin a pilot clinical trial of TETRANITE, its regenerative bone adhesive, for dental ridge augmentation. The study will assess the product’s ability to support bone grafting procedures without the use of membranes, meshes, tacks, or screws—offering a potential simplification to a […]
Samsung Bioepis has officially begun direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across Europe following the complete transfer of rights from Biogen. The move makes BYOOVIZ the fourth biosimilar now independently marketed by Samsung Bioepis in the region, joining EPYSQLI (eculizumab), OBODENCE (denosumab), and XBRYK (denosumab). The company also confirmed that a pre-filled […]
Fulgent Genetics acquires Bako Diagnostics and StrataDx to scale AI pathology, expand national reach, and advance precision medicine strategy. Read full analysis.
AstraZeneca PLC and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for use in patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment and are at high risk of recurrence. The designation is based on positive results […]
The recent FDA approval of Rubraca (rucaparib) for pre-chemotherapy use in BRCA-mutated metastatic castration-resistant prostate cancer marks a strategic inflection for the field. This expanded indication, driven by head-to-head superiority over docetaxel in the TRITON3 Phase 3 trial, positions BRCA mutations as the first molecular biomarker in prostate cancer to carry actionable, label-defining weight in […]
For much of the past two decades, monoclonal antibodies have dominated modern drug development. Their ability to bind with high specificity, block protein function, and engage immune mechanisms has transformed the treatment of cancer, autoimmune disorders, and infectious disease. But despite their blockbuster status, biologics have a blind spot. They are largely excluded from the […]
