Partners Eli Lilly and AstraZeneca got a leap ahead in the BACE inhibitor race as they secure a fast-track designation from the FDA for Phase III candidate…

The FDA his demanding more information about Sanofi's IGlarLixi, delaying a decision about the Type 2 diabetes product by three months.

Johnson & Johnson and Genmab have passed another milestone on the route to FDA approval of Darzalex as a second-line combination treatment for multiple…

A snapshot survey of biotech chiefs during the second quarter has shown that their confidence to be able to raise funds has doubled since Q1, but they are a…

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.

Gene therapy biotech Spark Therapeutics has posted new long-term data for its Phase III trial of voretigene neparvovec, an experimental treatment for patients…

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.