A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data…

Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from…

The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing, that says it reflects how stability testing has evolved since the…

Despite the Senate defeat of a measure allowing drug importation just a month ago, House and Senate Democrats are trying again: they’ve introduced new legislation that would allow imports of…

Pfizer’s Hospira is drawing scrutiny from the FDA in a warning letter for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and…