The CFDA aims to speed orphan meds to market with conditional OKs for drugs approved abroad, even without any in-China trial data.

GlaxoSmithKline dodged yet another generic Advair bullet. Hikma and Vectura's knockoff was struck down at FDA Thursday, and an approval later this year is…

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.

There is an expectation that biosimilars will reap billions of dollars in saving for U.S. consumers by 2020. But adoption could be slowed by a "rebate…

AstraZeneca is officially on the board with checkpoint inhibitor Imfinzi, which nabbed its first FDA approval Monday.

Novo Nordisk has moved to settle a whistleblower lawsuit alleging the company ran a “white-coat marketing scheme” to pump up sales of NovoLog, Victoza and…

Novartis got FDA approval today for Rydapt, its new breakthrough treatment for acute myeloid leukemia (AML), which is expected to generate more than $250…

Sanofi CEO Olivier Brandicourt has been criticized for failing to pull off a couple of big acquisitions, but his more mundane deal to get Boehringer Ingelheim’…

Regulatory