The European Commission has granted marketing authorisation in the European Union (EU) for Nubeqa® (darolutamide), an oral androgen receptor inhibitor (ARi). The approval is based on Phase III ARAMIS
The U.S. FDA compiles a list of off-patent drugs without an approved generic to encourage the development of copycats. Now, the Chinese authorities are rolling out a similar initiative, only with some
China’s anticorruption authorities have punished 48 officials found responsible for the Changchun Changsheng Life Sciences vaccine scandal that provoked public outrage last summer.
A global recall may get expanded beyond valsartan as regulators continue to find potentially cancer-causing impurities in other “sartan” products.
In June, pharmaceutical exporters from India had meetings with representatives from the China Food & Drugs Administration (CFDA) on the problems being faced by them in the Chinese market.
In our mid-2018 compliance review, we look at inspection challenges faced by companies across the world. In the first half of this year, manufacturing compliance challenges dominated headlines.