Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.

The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.

Gilead Sciences has received approval for Sovaldi from China's FDA, gaining a foothold in the world's largest hepatitis C market.

South Korean drug manufacturer Firson was slapped with a warning letter and placed on an import alert by the FDA.

Pfizer is leaning heavily on Celltrion for biosimilar development and manufacturing, but its South Korean partner has stumbled with an FDA inspection.

Four weeks after Germany pulled the manufacturing authorization for a Dr. Reddy’s plant in India, it has blocked a second one.

After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document…

The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.

Regulatory