FDA should issue a public health alert to warn consumers about potential health risks that may result from use of Herbalife dietary supplements and should remove the company's products from the market, pending further investigation of lead contamination, according to Christopher Grell, an attorney whose firm specializes in ephedra and dietary supplement litigation

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.