The FDA has picked apart the process of a Jubilant solid-dose plant in India and criticized it for repeating mistakes.

Lupin has indicated it has received another FDA warning letter as regulatory issues continue to pile up for the Indian drugmaker.

The FDA has approved a new generic of Diovan from India's Alkem to help relieve a shortage of the ubiquitous high blood pressure treatment.

The plant in India where Biocon makes the biosimilars it shares with Mylan was given a clean bill of health by the FDA last year—but not for long.

A third carcinogen was found in sartan drugs; China unveiled final rules for a Nasdaq-style board; Philippines preps to indict Sanofi officials.

Japan’s Nichi-Iko Pharmaceutical and its U.S. operation Sagent Pharmaceuticals have bought a plant in North Carolina from Xellia.

The detection of a third suspected cancer-causing contaminant in valsartan drugs has forced the FDA to again scramble to figure out risks.  

Daiichi rejigs management; China approves its first biosimilar; Sinovac uses a poison pill to fend off an investor takeover.