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

The European Medicines Agency today recommended approval of Imraldi, a Humira biosimilar from Samsung and Biogen.

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…

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.

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.

Regulatory