Andrew Simon

Andrew Simon

FDA Approves Lilly’s Retevmo® (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type

Tumor-agnostic data supporting approval demonstrated an overall response rate (ORR) of 44% across multiple tumor types FDA simultaneously grants traditional approval in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected…

Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial 

ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis Osteoporosis accounts for 8.9 million bone fractures annually, including debilitating hip fractures – a…