The FDA has slapped a complete response letter onto Amgen for its experimental med to treat a hormonal imbalance in dialysis patients, dashing its hopes of a…

Clovis Oncology shares were up by about 30% in trading after market close--driven by expectations for its rucaparib to treat advanced ovarian cancer, which was…

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…

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.