A federal judge hearing the bellwether lawsuit for "low-T" drug marketing decided the plaintiff’s case was suffering from a lack of support for some…

The White House budget director has suggested extending to Medicare the same kinds of rebates that drugmakers are required to provide to Medicaid.

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…

Already under pressure from lawsuits and Congress for its insulin pricing, Eli Lilly faces a pair of new state-level investigations.

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…

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