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.

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

Two months after snapping up Ariad, Takeda is getting a quick return. The Ariad-developed potential blockbuster Alunbrig won FDA approval Friday.

What could China's newly proposed foreign drug policy mean for multinational pharma companies, and how will it change the world’s second-largest pharma…

The FDA, which banned APIs coming from a Divi’s plant in India, has followed that with a warning letter that savages the facility for a lack of data integrity.

For nearly two years Teva struggled with impurity issues for an API manufactured at a plant in China.

Sun Pharma has had another setback in its manufacturing for the U.S. market with the FDA laying out nearly a dozen observations for a solid dose formulation…

Regulatory