GSK's Cervarix may have been the first HPV shot approved in mainland China, but Merck's Gardasil now has an opening to gain the lead.

The manufacturing problems at Sun Pharma’s key Halol, India, plant have again stymied approval of a new drug from Sun's novel drug development group,…

India’s Dr. Reddy’s Laboratories, which has been whiplashed repeatedly by FDA actions against its plants, saw its sales in the U.S. fall markedly in the last…

​​​​​​​Rocked by a corruption scandal in Korea, Novartis is working to strengthen and simplify its global ethics and compliance approach.

The CFDA aims to speed orphan meds to market with conditional OKs for drugs approved abroad, even without any in-China trial data.

The FDA has warned Vikshara Trading & Investments for its repeated efforts to keep inspectors from getting a look into its filthy plant.

The FDA has cited an Aurobindo sterile manufacturing plant in India for not doing everything it can to prevent contamination, according to a new report.

The FDA actually invited Mitsubishi Tanabe to file Radicava for U.S. approval based on data generated in Japan. Now, it's the first new ALS med in decades.

A recent report says that FDA inspections of Indian drugmakers tripled between 2010 and 2015, and that trend continues this year, with the latest to feel the…

FDA inspectors continue to roll through Dr. Reddy’s plants in India and continue to find issues along the way.

Regulatory