Switzerland-based CDMO Lonza said it has been given the green light by regulators for its $5.5 billion deal to buy U.S.-based contract capsule and drug…

With a patent loss looming, Takeda filed a citizen petition pushing the FDA to knock back generic Velcade competition.

The FDA released a warning letter sent to Chinese API maker Qinhuangdao Zizhu Pharmaceutical in April that outlined data integrity problems.

Earlier this month, the FDA banned all products being shipped to the U.S. by a Chinese API maker, and a new warning letter explains why. It appears the…

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.

Regulatory