Celltrion says its biosimilars for Herceptin and Rituxan could be approved this year after it made plant improvements to resolve and FDA warning letter.

Opdivo goes directly to the lucrative lung cancer market with its first nod in China, where nearly 800,000 new patients are diagnosed each year.

After more than two years of intense effort, Sun Pharma has returned its key plant to the good graces of the FDA.

Next stop on WuXi Biologic's rapid advance in biologics manufacturing is the Boston, Massachusetts area where it will build a $60 million facility.

Experts say China's data sharing rule may hinder drug R&D; FDA rejects Mylan and Biocon's Lantus biosim and more news.

A leading position in insulin, combined with new launches like GLP1 drug Victoza, could help Novo grow to DKK19 billion in China by 2025.

Turnaround efforts at IDT Australia now include an FDA warning letter.

Zai's new chief commercial officer, William Liang, oversaw the launch of Tagrisso in China, and had oncology leadership stints at BMS and Roche.