Aurinia Pharmaceuticals has posted positive new data for its experimental drug voclosporin for active lupus nephritis--but 12 deaths in the study's…

Heron Therapeutics has gained an FDA approval for its long-acting, anti-nausea drug Sustol. This comes after about 6 years of regulatory back-and-forth.

Investors knocked a few percentage points off Amarin’s share price after the firm added a second interim analysis to its Phase III cardiovascular disease trial…

The EMA is to continue accepting applications for adaptive approval after wrapping up a two-year pilot of the concept.

Sanofi and R&D partner Regeneron could have their experimental IL-6 inhibitor sarilumab approved in Europe by early 2017.

Adaptimmune has become one of the first companies to have a drug accepted into the EMA’s PRIME regulatory fast-track initiative.

Regulus Therapeutics saw its shares nosedive last month when the FDA put a clinical trial hold on its leading hep C candidate RG-101--but the company said this…

The FDA has granted breakthrough therapy status to J&J and Genmab's Darzalex as a second-line treatment for multiple myeloma, positioning it for a…