China's Food and Drug Administration proposed changes to its foreign drug approval rules in a bid to speed new, innovative meds to market.

Johnson & Johnson CEO Alex Gorsky played down the potential fallout from U.S. politics on his company—and the rest of pharma, for that matter.

Placing a company on the FDA import alert list does not guarantee its products won't get into the U.S., as a recent warning letter shows.

The FDA said in a warning letter that an Indian API maker had not ensured that water it gets from a nearby river is sanitary before using it to make its…

The race to snatch up generics maker Stada is heating up—and fast—with multiple players reportedly preparing to jump in, including Chinese drugmakers and,…

Wockhardt was hit with a seventh FDA warning letter, China's FDA chief pledged to speed up approvals of foreign drugs, and an Indian court ruled on patent…

Indian drugmakers Natco and Alembic won permission to export their copies of two on-patent Bayer blockbusters to aid other would-be generics makers.

CFDA's top official pledged to tackle barriers in drug approval to draw more advanced foreign drugs into the market.

Pharma Asia